Apparatus and method for use in positioning an anchor

ABSTRACT

An apparatus for use in positioning an anchor includes a tubular outer member and an inner or pusher member. During use of the apparatus, a slot facilitates visualization of the position of the anchor relative to body tissue. An anchor retainer may be provided at one end of the tubular outer member to grip the anchor and hold the anchor in place during assembly. The anchor retainer also holds the anchor during movement of the apparatus from an assembly location to an operating room or other location where the apparatus is to be used. Indicia may be provided on the inner member to indicate the position of the anchor relative to body tissue. The tubular outer member may be utilized to guide a drill during formation of an opening in body tissue and may be subsequently utilized to guide movement of an anchor into the opening in the body tissue.

RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No. 09/766,728 filed Jun. 22, 2001 now U.S. Pat. No. 6,428,562. The aforementioned application Ser. No. 09/766,728 is itself a continuation of U.S. patent application Ser. No. 09/479,647 field Jan. 7, 2000, now U.S. Pat. No. 6,312,448. The aforementioned application Ser. No. 09/479,647 is itself a divisional of U.S. patent application Ser. No. 09/343,371 filed Jun. 30, 1999, now U.S. Pat. No. 6,003,430. The aforementioned application Ser. No. 09/343,371 is itself a divisional of U.S. patent application Ser. No. 09/022,351 filed Feb. 11, 1998, now U.S. Pat. No. 5,948,002. The aforementioned application Ser. No. 09/022,351 is itself a continuation-in-part of U.S. patent application Ser. No. 08/752,005 filed Nov. 15, 1996, now U.S. Pat. No. 5,814,072. The benefit of the earlier filing dates of the aforementioned U.S. patent applications has been and hereby is claimed.

BACKGROUND OF THE INVENTION

The present invention relates to a new and improved method and apparatus for use in positioning an anchor, which may be a suture anchor, relative to the apparatus and/or relative to body tissue.

A known apparatus for use in positioning a suture anchor relative to body tissue includes a tubular member in which a suture anchor and a pusher member are received. During assembly of the apparatus it is necessary to position the suture anchor and a suture relative to the tubular member. Difficulty may be encountered in positioning the suture relative to the tubular member. In addition, difficulty may be encountered in retaining the suture anchor in a desired position relative to the tubular member.

When the known suture anchor inserter apparatus is to be utilized to position a suture relative to body tissue, a surgeon may encounter difficulty in visualizing the position of the suture anchor relative to the body tissue. In addition, difficulty may be encountered in disengaging the suture anchor inserter apparatus from the suture once the suture anchor has been positioned relative to the body tissue. Known apparatus for use in positioning a suture anchor relative to body tissue are disclosed in U.S. Pat. Nos. 5,258,016; 5,354,298; 5,403,348; and 5,464,426.

SUMMARY OF THE INVENTION

The present invention relates to a new and improved method and apparatus for use in positioning an anchor during assembly of the apparatus. The present invention also relates to a new and improved method and apparatus for use in positioning an anchor relative to body tissue. The apparatus includes a tubular outer member and an inner member which is received in a passage in the tubular outer member.

A slot may extend between openings at opposite ends of the tubular outer member. During positioning of the anchor relative to body tissue, the slot facilitates visualization of the anchor by a surgeon. Stop surfaces may be provided in association with the inner and outer members to facilitate moving the anchor to a desired position relative to the inner and outer members during relative movement between the inner and outer members.

In addition, the apparatus may include a retainer which holds an anchor in a desired position relative to the apparatus during assembly of the apparatus and during positioning of the anchor relative to body tissue. The retainer is deflected under the influence of force applied against the retainer by the anchor to enable the retainer to grip the anchor and hold the anchor in the desired position.

The retainer may engage a recess in the anchor. The recess may be formed by a passage in the anchor. Alternatively, the recess may be formed in an outer side surface of the anchor.

During positioning of the anchor relative to body tissue, the tubular outer member may be utilized as a guide for a drill which forms an opening in the body tissue. After the opening has been formed in the body tissue, the drill is removed from the tubular outer member and the anchor is moved along the tubular outer member into the body tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the invention will become more apparent upon a consideration of the following description taken in connection with the accompanying drawings wherein:

FIG. 1 is a simplified schematic illustration of the manner in which one apparatus constructed in accordance with the present invention may be utilized to position an anchor, which may be a suture anchor, in body tissue;

FIG. 2 is an enlarged fragmentary sectional view further illustrating the relationship between the anchor, a tubular outer member and an inner member of the apparatus of FIG. 1;

FIG. 3 is a sectional view, taken generally along the line 3—3 of FIG. 2, illustrating the relationship between the tubular outer member and inner member of the apparatus;

FIG. 4 is a schematic illustration depicting the manner in which the orientation of an anchor may be changed in the body tissue of FIG. 1;

FIG. 5 is a schematic illustration depicting the suture anchor of FIG. 4 after the anchor has been moved to a desired orientation in the body tissue;

FIG. 6 is a schematic illustration, generally similar to FIG. 1, illustrating a second embodiment of the apparatus;

FIG. 7 is an enlarged fragmentary sectional view illustrating the relationship between an anchor and a one-piece shaft of the apparatus of FIG. 6;

FIG. 8 is a sectional view, taken generally along the line 8—8 of FIG. 7 further illustrating the construction of the shaft of the apparatus;

FIG. 9 is a schematic illustration depicting the manner in which the orientation of the anchor may be changed in body tissue with the apparatus of FIGS. 6–8;

FIG. 10 is a schematic illustration depicting the relationship between an end portion of a shaft of a third embodiment of the apparatus and an anchor;

FIG. 11 is a fragmentary schematic pictorial illustration of one embodiment of another apparatus which is constructed and assembled in accordance with the present invention and is utilized to position an anchor, which may be a suture anchor, relative to body tissue;

FIG. 12 is a sectional view, taken generally along the line 12—12 of FIG. 11, illustrating the relationship between a tubular outer member and an inner member of the apparatus of FIG. 11;

FIG. 13 is a schematic illustration depicting the manner in which the apparatus of FIG. 11 is utilized to initially position an anchor relative to body tissue;

FIG. 14 is a schematic illustration, generally similar to FIG. 13, illustrating the manner in which the apparatus of FIG. 11 is utilized to move the anchor into an opening formed in the body tissue;

FIG. 15 is a schematic illustration depicting the manner in which the apparatus of FIG. 11 is utilized to change the orientation of the anchor relative to body tissue;

FIG. 16 is a fragmentary schematic pictorial illustration of a portion of an alternative embodiment of the apparatus of FIG. 11;

FIG. 17 is a sectional view, taken generally along the line 17—17 of FIG. 16, illustrating the manner in which a rotatable sleeve retains portion of a suture in a slot in a tubular outer member of the apparatus of FIG. 16, when the apparatus is used with an anchor which is a suture anchor;

FIG. 18 is a sectional view, generally similar to FIG. 16, illustrating the manner in which the sleeve is positioned relative to the tubular outer member to enable the suture to be moved out of the slot in the tubular outer member;

FIG. 19 is a fragmentary schematic illustration of an end portion of a tubular outer member of another embodiment of the apparatus illustrated in FIG. 11 and in which the end portion of the tubular outer member is contracted;

FIG. 20 is a fragmentary schematic illustration, generally similar to FIG. 19, illustrating the relationship between the end portion of the tubular outer member, an anchor, and an inner member after the end portion of the tubular outer member has been expanded and is effective to grip an outer side surface of the anchor;

FIG. 21 is a schematic sectional view depicting the manner in which a leading end of the anchor of FIG. 20 is moved into engagement with the contracted end portion of the tubular outer member of FIG. 19;

FIG. 22 is a schematic sectional view, generally similar to FIG. 21, depicting the manner in which the end portion of the tubular outer member of FIG. 19 is resiliently deflected outward by the anchor as the anchor moves to the position shown in FIG. 20;

FIG. 23 is a schematic illustration, generally similar to FIG. 22, of a another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating the manner in which a projection on the end portion of a tubular outer member engages a recess in an anchor;

FIG. 24 is a schematic sectional view, generally similar to FIGS. 21 and 22, of a projection on an end portion of a tubular outer member of an apparatus which forms another embodiment of the invention having the same general construction as the embodiment of FIG. 11;

FIG. 25 is a schematic sectional view illustrating the manner in which the projection on the end portion of the tubular outer member of FIG. 24 engages an end portion of a passage in an anchor;

FIG. 26 is a schematic sectional view, generally similar to FIG. 24, of another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating a pair of projections on an end portion of a tubular outer member;

FIG. 27 is a schematic sectional view illustrating the manner in which the projections of FIG. 26 engage the end portions of a pair of passages in an anchor;

FIG. 28 is a schematic sectional view of another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating the manner in which a spring on a tubular outer member engages an end portion of a passage in an anchor;

FIG. 29 is a schematic sectional view of another embodiment of the invention, having the same general construction as the embodiment of FIG. 1 and illustrating the manner in which a spring on an inner member engages an end portion of a passage in an anchor;

FIG. 30 is a schematic sectional view of another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating a contracted end portion of a tubular outer member as an anchor is moved toward the end portion of the tubular outer member;

FIG. 31 is a schematic pictorial illustration of a tubular outer member which forms a portion of another embodiment of the invention;

FIG. 32 is a schematic pictorial illustration of an inner member which is utilized to position an anchor relative to the tubular outer member of FIG. 31;

FIG. 33 is a schematic pictorial illustration of an inner member which is used to move an anchor out of the tubular outer member of FIG. 31;

FIG. 34 is a schematic pictorial illustration depicting the manner in which an anchor is inserted into the tubular outer member of FIG. 31;

FIG. 35 is a schematic pictorial illustration depicting the manner in which the anchor is moved along a passage in the tubular outer member of FIG. 31 by the inner member of FIG. 32;

FIG. 36 is a schematic pictorial illustration depicting the manner in which the anchor is positioned relative to the tubular outer member of FIG. 31 by the inner member of FIG. 32;

FIG. 37 is a schematic sectional view, taken generally along the line 37—37 of FIG. 36, illustrating the manner in which a projection on an outer end portion of the tubular outer member of FIG. 31 engages an outer side surface of the anchor after the anchor has been positioned by the inner member of FIG. 32;

FIG. 38 is a schematic sectional view of another embodiment of the tubular outer member illustrated in FIG. 31 and illustrating an outwardly flaring or funnel-shaped end portion on the tubular outer member;

FIG. 39 is a schematic sectional view of another embodiment of the invention and illustrating the manner in which a stop element connected with an inner member engages an end portion of a tubular outer member having a construction similar to the construction of the tubular outer member of FIG. 31;

FIG. 40 is a schematic sectional view illustrating the manner in which the stop element moves along a slot in the tubular outer member of FIG. 39 during insertion of an anchor into body tissue;

FIG. 41 is a schematic sectional view of another embodiment of the invention and illustrating the relationship between a stop element on an inner member and index recess formed in a tubular outer member having a construction similar to the construction of the tubular outer member of FIG. 31;

FIG. 42 is a schematic sectional view of another embodiment of the invention, and illustrating the manner in which a resiliently deflectable stop element on an inner member engages an end of a tubular outer member having a construction similar to the construction of the tubular outer member of FIG. 31; and

FIG. 43 is a fragmentary schematic sectional view depicting the manner in which a tubular outer member having the same general construction as the tubular outer member of the embodiment of the invention illustrated in FIG. 11, is utilized in association with a thin elongated member to guide movement of a drill relative to body tissue.

DESCRIPTION OF ONE SPECIFIC PREFERRED EMBODIMENT OF THE INVENTION

Anchor Inserter

An anchor inserter apparatus 20, constructed in accordance with the present invention, is illustrated in FIG. 1. The apparatus 20 includes a manually engageable handle 22 and a shaft 24 which extends from the handle. A leading end portion 26 (FIG. 2) of the apparatus 20 extends through a passage 28 in an anchor 30. The specific anchor 30 illustrated in FIG. 2 happens to be a suture anchor. A suture 32 engages the anchor 30. The anchor 30 could have a construction other than the illustrated construction. The anchor 30 could be constructed so as to be used without the suture 32.

The illustrated anchor 30 has a cylindrical tubular side wall 36 (FIG. 2). A trailing end portion 38 of the anchor 30 has a flat annular trailing end surface 42. In addition, the anchor 30 has a leading end portion 44. The leading end portion 44 of the anchor 30 has an annular leading end surface 46.

The tubular side wall 36 of the anchor 30 has a cylindrical outer side surface 50 which extends between the trailing end surface 42 and the leading end surface 46. In addition, the illustrated anchor 30 has a cylindrical inner side surface 52 which is disposed in a coaxial relationship with the outer side surface 50. The cylindrical inner side surface 52 forms the passage 28 which extends between the trailing end surface 42 and leading end surface 46 of the anchor 30.

A groove or slot 56 is formed in the leading end portion 44 of the anchor 30. The groove or slot 56 extends axially inward from the leading end surface 46 and extends radially between the outer and inner side surfaces 50 and 52 of the anchor 30. The slot or groove 56 has an arcuately curving inner side surface 58 across which the suture 32 extends. It is contemplated that the slot or groove 56 may be omitted if desired.

The suture 32, which is used with the specific anchor 30 illustrated in FIGS. 1 and 2, has an outer leg 62 which extends along the outer side surface 50 of the anchor. An inner leg 64 of the suture 32 extends through the passage 28 and along the inner side surface 52 of the anchor 30. The outer leg 62 and inner leg 64 of the suture 32 are interconnected by a connector section 66 of the suture. The connector section 66 of the suture 32 extends through the slot 56 in the side wall 36 of the anchor 30. If the anchor 30 is constructed without the slot 56, the connector section 66 of the suture 32 would extend across the leading end surface 46 of the anchor.

The anchor 30 is made of a biocompatible material, specifically, stainless steel. The anchor 30 has a length, that is, the distance between the trailing end surface 42 and leading end surface 46, of approximately two millimeters. The anchor 30 has an outside diameter, that is, the diameter of the outer side surface 50, of approximately one millimeter. The inner side surface 52 has a diameter of about one-half millimeter. It should be understood that the foregoing specific dimensions for one specific anchor 30 have been set forth herein only for purposes of clarity of description. It is contemplated that the anchor 30 will be constructed with dimensions which are different than the dimensions set forth above.

The illustrated anchor 30 has a cylindrical tubular side wall 36. It should be understood that the anchor 30 could have a different configuration. For example, the anchor 30 could have a polygonal cross sectional configuration if desired. Thus, the anchor 30 could have a polygonal configuration which is similar to the polygonal configuration of an anchor disclosed in U.S. Pat. No. 5,549,630 issued Sep. 27, 1996 to Peter M. Bonutti.

Although the anchor 30 is formed of metal, it is contemplated that the anchor 30 could be formed of other materials if desired. For example, the anchor 30 could be formed of body tissue. Alternatively, the anchor 30 could be formed of a polymeric material such as cellulose, petroylglutamic acid, collagen, or polylactide. It is believed that a ceramic as found in hydroxyapatite composites with polyethylene, polylactide or polyhydroxybutyrate may be utilized to form the anchor 30. If desired, the anchor 30 may be formed of a material which is hydrophilic and expands when exposed to body fluids.

The shaft 24 has a leading end portion 72 (FIGS. 1 and 2) which is used to penetrate human body tissue. The leading end portion 72 of the shaft extends through the anchor 30. The leading end portion 72 of the shaft 24 may have a point 76 which extends ahead of the leading end surface 46 of the anchor 30.

The illustrated point 76 on the inserter shaft 24 has a conical configuration with a central axis which is coincident with a central axis of the inserter shaft and anchor 30. However, if desired, the point 76 could have a wedge-shaped configuration. Similarly, the point 76 could be formed by a single flat plane which is skewed at an acute angle to a longitudinal central axis of the shaft 24. Alternatively, the leading end of the shaft 24 could have a rounded or even a flat configuration.

The leading end portion 72 of the shaft 24 extends through the passage 28 in the anchor 30. The point 76 on the leading end of the shaft 24 is disposed ahead of and is coaxial with the anchor 30. This enables the point 76 to pierce body tissue ahead of the anchor 30. Although it is believed that the provision of the point 76 on the leading end of the shaft 24 will facilitate the piercing of human body tissue, the cross sectional size of the leading end of the shaft may be so small as to enable the shaft to pierce body tissue with a blunt end.

By piercing the body tissue with the point 76, an opening is initially formed by the leading end portion 72 of the shaft 24. The shaft 24 moves the anchor into the opening which was initially formed by the point 76. The leading end surface 46 on the anchor 30 is sloped to form a continuation of a surface 80 on the point 76. The sloping leading end surface 46 on the anchor 30 promotes a smooth enlargement of the opening formed in the elastic material of the human body tissue by the point 76 on the leading end of the shaft 24. Although the point 76 is advantageously used to pierce soft body tissue, the inserter 20 may be used to position anchors 30 in preformed openings in hard body tissue, such as bone.

The shaft 24 may be used to promote movement of the anchor 30 in human body tissue in such a manner as to change the orientation of the anchor relative to the body tissue and the shaft 24. Thus, it may be desired to change the orientation of the anchor 30 relative to the shaft 24 from the orientation shown in FIG. 1 to the orientation shown in FIG. 5. However, it should be understood that the inserter 20 may also be used to position anchors 30 which remain in the orientation shown in FIG. 1 relative to the body tissue.

When the anchor 30 is used with a suture and it is desired to change the orientation of an anchor 30 relative to body tissue, a leg 62 of the suture 32 is tensioned in the manner indicated by an arrow 84 in FIG. 4. At the same time, the point 76 on the shaft 24 engages the inner side surface 52 of the passage 28 through the anchor 30. This results in the application of a torque to the anchor 30 tending to rotate the anchor in a clockwise direction (as viewed in FIG. 4) from the orientation shown in FIG. 1 through the orientation shown in FIG. 4, toward the orientation shown in FIG. 5.

As this occurs, the cylindrical outer side surface 50 of the anchor is pressed against the elastic material of human body tissue 88 and deforms the body tissue. Once the anchor has been moved to the orientation shown in FIG. 5, pulling out of the anchor from the body tissue 88 is resisted by the relatively large outer side surface 50 of the anchor. This enables the anchor to remain stable in the body tissue 88 even though relatively large forces are applied to the legs 62 and 64 of the suture 32. Although the foregoing description has related to the changing of the orientation of the anchor 30 in soft body tissue, the inserter 20 may be used to change the orientation of an anchor in cancellous bone tissue in the same manner as previously set forth in association with soft body tissue.

The foregoing description has been in conjunction with an anchor 30 which is used with a suture 32. However, the suture 32 could be omitted if desired. If this is done, the anchor 30 would be used to retain body tissue.

Inserter

The anchor inserter 20 (FIG. 1) includes a handle 22 having a configuration suitable for manual grasping by a surgeon. The illustrated handle 22 has a generally cylindrical configuration with circumferentially extending grooves to facilitate firm gripping of the handle. However, if desired, the handle 22 could be formed with a generally triangular cross sectional configuration in a manner similar to that disclosed in U.S. application Ser. No. 08/673,923 filed Jul. 1, 1996 and entitled “Suture Anchor Inserter Assembly and Method” by Peter M. Bonutti. The disclosure in the aforementioned application Ser. No. 08/673,923 is incorporated herein in its entirety by this reference thereto.

The shaft 24 extends axially outward from the handle 22. The shaft 24 has a generally cylindrical configuration and is disposed in a coaxial relationship with the handle 22. However, the shaft 24 could have a different configuration if desired. For example, if the passage 28 through the anchor 30 had a polygonal cross sectional configuration, the shaft 24 could have a corresponding polygonal cross sectional configuration.

In accordance with a feature of the embodiment of the inserter 20 illustrated in FIGS. 1–3, the shaft 24 includes a cylindrical inner member 92 and cylindrical outer member 94 which are movable relative to each other. The upper (as viewed in FIGS. 1 and 2) end of the solid cylindrical inner member 92 is fixedly connected with the handle 22. The point 76 is disposed on the lower (as viewed in FIGS. 1 and 2) end of the inner member 92. The point 76 extends ahead of the leading end portion 44 of the anchor 30 to initiate formation of an opening into which the anchor moves.

As was previously mentioned, the point 76 could be formed with a configuration other than the illustrated conical configuration. In fact, it is contemplated that the point 76 may be eliminated on some embodiments of the inserter. Although it is preferred to have the inner member 92 extend through the passage 28 and extend ahead of the leading end portion 44 of the anchor 30, the leading end of the inner member 92 could be disposed in the anchor if desired.

The outer member 94 has a tubular cylindrical configuration and partially encloses the solid inner member 92. The outer member 94 is axially movable relative to the inner member 92. The outer member 94 has a flat annular pusher surface 98 which engages the flat annular trailing end surface 42 of the anchor 30.

The inner and outer members 92 and 94 are both formed of metal, specifically stainless steel. However, the inner and outer members 92 and 94 could be formed of other materials if desired. For example, the inner member 92 could be formed of metal and the outer member 94 could be formed of a polymeric material.

The outer member 94 is axially movable along the inner member 92 between a retracted position, shown in FIGS. 1 and 2, and a fully extended position in which the pusher surface 98 is adjacent to the lower (as viewed in FIG. 2) end of the point 76. Thus, the outer member 94 is movable axially along the inner member 92 from the position shown in FIGS. 1 and 2 through the position shown in FIG. 4 to a position in which the annular pusher surface 98 is a short distance past the outer end of the point 76.

In accordance with one of the features of the present invention, a slot or groove 102 (FIG. 3) extends through a tubular cylindrical side wall of the outer member 94. The straight slot or groove 102 in the outer member 94 extends between opposite ends of the outer member 94 and is axially aligned with a passage, that is a slot, which extends through the handle 22. The two legs 62 and 64 of the suture 32 extend through the slot 102 and the passage in the handle 22 to a location disposed above (as viewed in FIG. 1) the handle.

The inner leg 64 of the suture 32 extends through the passage 28 (FIG. 2) in the anchor 30. The leading end portion of the inner member 92 also extends through the passage 28 in the anchor 30. In the illustrated embodiment of the inserter 20, a straight slot or groove 106 extends axially along the inner member 92 from the point 76 to a location which is disposed above (as viewed in FIG. 2), the pusher surface 98 when the outer member 94 is in the retracted position. The inner leg 64 of the suture then extends from the slot 106 in the inner member 92 into the slot 102 in the outer member 94. The slot 106 in the inner member 92 terminates at a location disposed axially above (as viewed in FIG. 2) the pusher surface 98 when the pusher surface is in the retracted position.

An actuator 110 is provided to move the outer member 94 axially along the inner member 92. The actuator 110 (FIG. 1) includes a manually engageable knob or input member 112 which is connected to the outer member 94 and extends through a slot 114 formed in the handle 22. The slot 114 has an axial extent which corresponds to the distance which the outer member 94 can be moved axially along the inner member 92. When the outer member 94 is in the fully retracted position of FIG. 1, the knob 112 is adjacent to an upper end of the slot 114.

After the anchor 30 has been moved into body tissue 88 and is to remain in the orientation shown in FIG. 1, the actuator knob 112 is moved downward (as viewed in FIG. 1) in the slot 114. As this occurs, force is transmitted between the pusher surface 98 and the trailing end surface 42 of the anchor 30. At the same time, the shaft 24 may be moved straight upward (as viewed in FIG. 1).

The relative movement between the anchor 30 and inner member 92 results in the trailing end surface 42 of the anchor 30 being moved in alignment with the base or upper end of the point 76. When this has happened, a cylindrical outer side or positioning surface 120 on the inner member 92 is disposed above (as viewed in FIG. 2) the annular trailing end surface 42 of the anchor 30. Continued relative movement between the inner and outer members 92 and 94 at least partially withdraws the point 76 from the passage 28 in the anchor 30. The handle 22 of the inserter 20 can then be moved or pulled upward away from the body tissue 88 and the point 76 of the shaft 24 moved completely out of the anchor 30. This results in the anchor 30 remaining in the orientation shown in FIG. 1 in the body tissue 88.

As the outer member 94 is moved axially downward (as viewed in FIGS. 1 and 2) to separate the anchor from the shaft 24, the extent of the telescopic relationship between the portions of the inner and outer members 92 and 94 disposed in the handle 22 is decreased. Thus, when the outer member 94 is in the fully retracted position shown in FIG. 1, the extent to which the portion of the inner member 92 disposed in the handle is enclosed by the outer member 94 is a maximum. As the actuator knob 112 is moved downward (as viewed in FIG. 1) in the slot 114, a portion of the outer member 94 moves out of the handle 22 and the extent of the telescopic relationship between the inner and outer members 92 and 94 in the handle 22 decreases.

The length of the slot 114 is great enough to enable the pusher surface 98 to move along the length of the point 76. When the actuator knob 112 has reached the lower end (as viewed in FIG. 1) of the slot 114, the upper end portion of the outer member 94 is still in the handle 22. At this time, the pusher surface 98 has moved to a location just past the point 76. Therefore, the point 76 is fully enclosed by the outer member 94.

It should be understood that a surgeon using the inserter 20 can determine the extent of relative movement between the inner and outer members 92 and 94. The surgeon may move the actuator knob 112 through only a portion of the length of the slot 114. Suitable indicia may be provided along the slot 114 to indicate the position of the pusher surface 98 relative to the point 76.

In the embodiment of the invention illustrated in FIG. 1, the actuator knob 112 is connected directly with the outer member 94 and is movable in the slot 114 in the handle 22. However, it is contemplated that the actuator knob 112 and the slot 114 could be eliminated and suitable knurling and/or projections provided on the outer member 94. The knurling or projections on the outer member 94 may be manually engaged and force transmitted directly from the hand of a surgeon to the outer member. If force is to be manually applied directly to the outer member 94, the outer member could either extend into the handle 22 or terminate short of the handle.

Insertion of Anchor

When the anchor 30 is to be inserted into body tissue 88, the optional suture 32 extends through the passage 28 in the anchor 30. The legs 62 and 64 of the suture 32 extend along the slot 102 in the outer member 94 and through the passage (not shown) in the handle 22. However, if desired, the legs 62 and 64 of the suture 32 could extend along the outside of the shaft 24 and handle 22. If desired, the suture 32 could be omitted.

The anchor 30 is then positioned on the leading end portion 26 of the inserter 20. Since the specific anchor 30 illustrated in the drawings is a suture anchor, the suture 32 extends through the passage 28 in the anchor and with the outer member 94 in the retracted position of FIGS. 1 and 2. It should be understood that the suture 32 could be connected with the anchor 30 in a manner other than by extending through the passage 28. For example, an opening could be provided in the anchor 30 at a location spaced from the passage 28. The suture 32 could extend through or be tied off at this opening.

To position the anchor 30 on the leading end portion 26 of the shaft 24, the point 76 on the inner member 92 is inserted into the passage 28 in the anchor 30. The slot 106 in the inner member 92 is aligned with the inner leg 64 of the suture. The anchor is then moved along the inner member 92 until the trailing end surface 42 on the anchor moves into abutting engagement with the pusher surface 98 on the outer member 94. At this time, the point 76 on the inner member 92 extends outward from and is coaxial with the end surface 46 of the anchor 30. The suture 32 is then tensioned to hold the anchor 30 in place.

The point 76 on the inner member 92 is then moved into engagement with an imperforate outer surface 130 (FIG. 1) on a human patient's skin 132. Manual force is applied to the handle 22 to cause the point 76 on the inner member 92 to pierce the surface 130. As this occurs, a circular opening is formed in the skin 132 by the point 76 of the inner member 92. This opening is formed directly ahead of and in axial alignment with the anchor 30.

The manual application of downward (as viewed in FIG. 1) force against the handle 122 moves the point 76 of the inner member 92 through the skin 132 into flesh 134 disposed beneath the skin. As this occurs, the leading end portion 44 of the anchor 30 moves into the opening which was initially formed by the point 76 on the inner member 92. The annular pusher surface 98 on the outer member 94 presses against the annular trailing end surface 42 of the anchor 30 to push the anchor into the body tissue.

Movement of the leading end portion 44 of the anchor 30 into the opening formed by the point 76 in the body tissue is facilitated by having at least a portion of the leading end surface 46 of the anchor 30 slope radially outward as a continuation of the surface 80 on the point 76. As the leading end 44 of the anchor 30 is pressed against the viscoelastic body tissue 88, the initial opening is elastically expanded and the anchor 30 moves into the flesh 134 disposed beneath the skin 132. The point 76 pierces the flesh 134 ahead of the anchor 30 to initiate the formation of an opening in the flesh for the anchor.

Continued application of force to the handle 22 results in the shaft 24 moving the anchor 30 to a desired depth in the body tissue 88. As this occurs, the point 76 on the inner member 92 continues to penetrate or pierce the body tissue 88 ahead of the anchor 30. This facilitates movement of the shaft 24 and anchor 30 into the body tissue 88.

The anchor 30 is moved into the body tissue 88 under the influence of force transmitted from the pusher surface 98 on the outer member 94 to the trailing end surface 42 of the anchor. Thus, as the shaft 24 and anchor 30 move into the body tissue 88, the outer member 94 is stationary relative to the inner member 92. The pusher surface 98 on the outer member 94 presses against the trailing end portion 38 of the anchor 30 with a force sufficient to move the anchor into the body tissue 88.

Once the anchor 30 has been moved into the body tissue 88, the anchor and shaft 24 are separated. When this is to be done, any tension in the legs 62 and 64 of the suture is eliminated. The actuator knob 112 is then moved downward (as viewed in FIG. 1) along the slot 114. As this occurs, relative movement between the anchor 30 and the inner member 92 results in the point 76 (FIG. 2) on the inner member being circumscribed by the tubular side wall 36 of the anchor.

When the anchor 30 is being separated from the inserter 20, the anchor may be pushed off of the end of the inner member 92 by the outer member 94 while the inner member remains stationary relative to the body tissue. Alternatively, the handle 22 and inner member 92 may be moved upwardly and the anchor 30 and outer member 94 maintained stationary relative to the body tissue. It is contemplated that, in all probability, there will be a combined movement of the anchor 30 and outer member 94 axially along the inner member 92 and withdrawal of the inner member from the body tissue as the anchor is separated from the shaft 24.

Changing Anchor Orientation

As the anchor 30 is separated from the shaft 24, it may remain in the orientation shown in FIG. 1 relative to the body tissue 88 and the shaft. Alternatively, the anchor 30 may be moved through the orientation shown in FIG. 4 to the orientation shown in FIG. 5. At least a portion of this movement of the anchor 30 occurs while the leading end portion 26 of the inserter 20 is in the passage 28 in the anchor.

During movement of the anchor 30 to a desired depth in the body tissue 88 (FIG. 1), the outer side surface 120 on the inner member 92 positions the anchor in a coaxial relationship with the inner member 92 and retains the anchor against pivotal movement. When the anchor 30 has been moved to the desired depth in the body tissue 88, the actuator 110 is manually operated. This causes relative movement between the inner and outer members 92 and 94.

As relative movement occurs between the inner and outer members 92 and 94, the point 76 on the outer member and the pusher surface 98 on the inner member move toward each other (FIG. 4). As this occurs, the positioning surface 120 on the inner member 92 almost moves out of the passage 28 in the anchor 30 (FIG. 4). This releases the anchor 30 for pivotal movement relative to the shaft 24. Although a major portion of the positioning surface 120 has been withdrawn from the anchor passage 28, the point 76 on the inner member 92 and the outermost portion of the positioning surface 120 are disposed in the passage 28 in the anchor.

Pivotal movement of the anchor 30 is then initiated by tensioning the outer leg 62 of the suture 32, as indicated by the arrow 84 in FIG. 4. The tension force applied to the leading end portion 44 of the anchor 30 causes it to rotate in a clockwise direction toward the position shown in FIG. 4. As the anchor approaches the position shown in FIG. 4, the inner side surface 52 on the anchor 30 moves into engagement with the outer side surface 80 on the point 76. This results in the transmittal of force from the outer side surface 80 of the point 76 to the inner side surface 52 of the anchor 30 in a downward (as viewed in FIG. 4) direction to further promote pivotal movement of the anchor in a clockwise direction.

As the outer member 94 continues to push downward (as viewed in FIG. 4) against the trailing end surface 42 of the anchor 30, the anchor continues to pivot relative to the shaft 24. The anchor 30 pivots about a location where the trailing end surface 42 of the anchor engages the outer member 94. In addition, the anchor 30 pivots about a location where the point 76 engages the inner side surface 52 of the anchor. This combined pivotal movement is caused by the tension in the outer leg 62 of the suture 32.

As the pusher surface 98 approaches and then moves past the base of the point 76, the point moves out of the passage 28 through the anchor 30. The anchor 30 then continues to pivot in a clockwise direction under the influence of the force applied to the anchor by the tension in the outer leg 62 of the suture 32. This force causes the anchor to move to the position shown in FIG. 5, or at least to a position closely approximating the position shown in FIG. 5. Once the anchor 30 has moved to the position shown in FIG. 5 relative to the body tissue 88, the relatively large outer side surface 50 of the anchor resists pulling out of the anchor from the body tissue. Therefore, relatively large forces can be transmitted through the suture 32 to the anchor 30 without pulling the anchor out of the body tissue.

When the anchor 30 is to be inserted into bone with the inserter 20, an opening is drilled through the hard outer layer of the bone into the soft inner material of the bone. Once this has been done, the inserter 20 is used to position the anchor 30 in the spongy cancellous tissue within the bone. The orientation of the anchor 30 may be changed, relative to the bone, in the same manner as previously explained herein.

It should be understood that it is contemplated that the inserter 20 may be used to position an anchor 30 in either hard or soft tissue at many different locations in a patient's body. The pointed end 76 of the inserter 20 may be used to pierce body tissue at locations remote from the patient's skin 132 (FIG. 1). Thus, the inserter 20 may be used to position an anchor in an organ disposed within the patient's body.

When the inserter 20 is to be used to position the anchor 30 in a preformed opening in hard body tissue, such as the hard outer or cortical layer of bone, the inner member 92 may not extend past the leading end portion 44 of the anchor 30. When the inserter 20 is to be used to position the anchor 30 in soft body tissue, the formation of an opening in the body tissue for the anchor 30 may be accomplished without piercing the body tissue with the inner member 92 and the inner member may not extend past the anchor. However, it is believed that it may be preferred to have the point 76 extend ahead of the anchor 30 even when the point is not to be used to pierce body tissue.

Inserter—Second Embodiment

In the embodiment of the inserter or apparatus illustrated in FIGS. 1–5, the shaft 24 is formed by two members, that is, the inner member 92 and the outer member 94. In the embodiment of the inserter illustrated in FIGS. 6–9, the shaft of the inserter is formed by a single member. Since the embodiment of the invention illustrated in FIGS. 6–9 is generally similar to the embodiment of the invention illustrated in FIGS. 1–5, similar numerals will be utilized to designate similar components, the suffix letter “a” being associated with the numerals of FIGS. 6–9 to avoid confusion.

An anchor inserter 20 a (FIG. 6) includes a manually engageable handle 22 a and a one piece shaft 24 a which extends outward from the handle. A leading end portion 26 a of the one piece shaft 24 a extends through a passage 28 a in the anchor 30 a. Since the illustrated anchor 30 a is a suture anchor, a suture 32 a extends through the passage 28 a in the anchor and along the shaft 24 a. The suture 32 a extends through a passage (not shown) in the handle 22 a. The anchor 30 a has the same construction as the anchor 30 in the embodiment of the invention illustrated in FIGS. 1–5. However, the anchor 30 a could have a different construction if desired. The anchor 30 a could be used without the suture 32 a if desired.

The shaft 24 a of the inserter 20 a is formed as one piece. Thus, the shaft 24 a includes a main section 142 (FIGS. 6 and 7) and a leading end section 144 (FIG. 7). The leading end section 144 includes a cylindrical positioning portion 146 which is disposed in a coaxial relationship with the cylindrical main section 142. A generally conical point 76 a is formed on the leading end section 144 and has a conical outer side surface 80 a.

A pusher surface 98 a forms a flat annular shoulder where the cylindrical main section 142 is connected with the leading end section 144 of the shaft 24 a. Since the shaft 24 a is formed from a single piece of material, that is, stainless steel, the pusher surface 98 a does not move relative to the point 76 a of the shaft 24 a. Although it is preferred to form the shaft 24 a from a single piece of metal, the shaft may be formed by a solid cylindrical inner member and a cylindrical tubular outer member which is fixedly connected to the inner member. When the shaft 24 a is formed by two fixedly connected members, the members may be different materials.

A slot 102 a (FIGS. 7 and 8) extends from the base of the point 76 a along the shaft 24 a. The slot 102 a extends through the handle 22 a. The depth of the slot 102 a is greater in the main section 142 (FIG. 7) of the one piece shaft 24 a than in the leading end section 144 of the shaft. The inner and outer legs 62 a and 64 a of the suture 32 a are received in the slot 102 a (FIG. 8) when he inserter 20 a is used to position a suture anchor relative to body tissue.

When the anchor 30 a is to be inserted into human body tissue 88 a (FIG. 6), the anchor is first positioned on the leading end section 144 of the shaft 24 a with the suture 32 a extending through the passage 28 a in the anchor 30 a. Thus, the anchor 30 a is telescopically moved onto the positioning portion 146 of the leading end section 144 of the shaft 24 a. As this occurs, a trailing end surface 42 a on the anchor 30 a is positioned in abutting engagement with the annular pusher surface 98 a.

A cylindrical outer side surface 120 a on the positioning portion 146 engages a cylindrical inner side surface 52 a of the anchor 30 a (FIG. 7). The positioning surface 120 a on the leading end section 144 of the shaft 24 a positions the anchor 30 a in a coaxial relationship with the shaft 24 a and the point 76 a. When the anchor 30 a is a suture anchor, the two legs 62 a and 64 a of the suture 32 a are tensioned to hold the trailing end surface 42 a of the anchor 30 a in abutting engagement with the pusher surface 98 a on the shaft 24 a.

The point 76 a on the leading end section 144 of the shaft 24 a is then moved into engagement with an imperforate outer surface 130 a (FIG. 6) of a human patient's skin 132 a. A downward force is then manually applied to the handle 22 a. This force causes the point 76 a on the shaft 24 a to pierce the outer side surface 130 a of the skin 132 a. The point 76 a then moves into flesh 134 a disposed beneath the skin. As this occurs, an opening is formed by the point 76 a in the skin 132 a.

The anchor 30 a moves into the opening in the skin 132 a. Force is applied against the trailing end surface 42 a of the anchor 30 a by the pusher surface 98 a to push the anchor into the body tissue 88 a. A leading end surface 46 a on the anchor 30 a is sloped so as to form a continuation of the outer side surface 80 a of the point 76 a. This results in a smooth enlargement or stretching of the circular opening which is initially formed in the skin 132 a by the point 76 a of the shaft 24 a. As the shaft 24 a and anchor 30 a continue to move downward (as viewed in FIG. 6) into the flesh 134 a beneath the skin 132 a, the point 76 a on the shaft 24 a pierces the body tissue to facilitate movement of the anchor 30 a into the body tissue.

Once the anchor 30 a has been moved to the desired depth in the body tissue, the anchor is separated from the shaft 24 a. This may be done by merely withdrawing the leading end section 144 of the shaft 24 a from the anchor 30 a while the anchor remains in the orientation shown in FIG. 6 in the body tissue 88 a. It is contemplated that there will be relatively little friction between the outer side surface 120 a on the positioning portion 146 of the shaft 24 a and the inner side surface 52 a. This enables the anchor to be held in position in the body tissue 88 a by the resilient force applied against the anchor 30 a by the body tissue as the inserter 20 a is withdrawn from the anchor.

It is contemplated that it may be desired to apply force against the trailing end surface 42 a of the anchor 30 a to facilitate separation of the shaft 24 a from the anchor 30 a. If this is the case, a cylindrical pusher rod 150 (FIG. 7) may be provided in a suitable passage formed in the solid shaft 24 a. An actuator 110 a has a knob 112 a which is connected with the pusher rod 150 and is movable along a slot 114 a formed in the handle 22 a.

When the shaft 24 a is to be withdrawn from the anchor 30 a, the actuator knob 112 a is moved downward. This results in the pusher rod 150 moving downward (as viewed in FIG. 7) relative to the shaft 24 a. A circular leading end surface on the pusher rod 150 applies force against the trailing end surface 42 a of the anchor to facilitate separation of the shaft from the anchor. It should be understood that the pusher rod 150 is optional and may be omitted if desired.

It is believed that in certain situations at least, it will be desired to change the orientation of the anchor relative to the body tissue 88 a and the shaft 24 a as the shaft 24 a and anchor 30 a are separated. To accomplish this, the leg 62 a of the suture 32 a is tensioned, in the manner indicated by the arrow 84 a in FIG. 9 as the shaft 24 a is withdrawn from the anchor. This results in pivoting movement of the anchor relative to the shaft 24 a in the same manner as previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 1–5.

It is believed that the use of the pusher rod 150 to apply force against a side of the anchor 30 a opposite from the suture 32 a will promote pivoting movement of the anchor. In addition, pivoting movement of the anchor 30 a is promoted by engagement of the outer side surface 80 a on the point 76 a of the shaft 24 a with the inner side surface 52 a of the anchor. It should be understood that the anchor 30 a moves through the orientation shown in FIG. 9 to the orientation shown in FIG. 5 for the anchor 30.

It is contemplated that the point 76 a may have a configuration which is different than the illustrated conical configuration. For example, the point 76 a could be formed by a single flat side surface which is skewed relative to a central axis of the shaft 24 or by a plurality of skewed flat side surfaces which intersect at the central axis of the shaft. Alternatively, the end of the end section could have a blunt or flat configuration rather than the illustrated pointed configuration.

Third Embodiment of Inserter

In the embodiments of the inserter illustrated in FIGS. 1–9, the anchor is retained on the shaft of the inserter prior to insertion of the anchor into body tissue. In the embodiment of the invention illustrated in FIG. 10, the inserter includes a spring which is utilized to retain the anchor on the shaft of the inserter. Since the embodiment of the invention illustrated in FIG. 10 is generally similar to the embodiments of the invention illustrated in FIGS. 1–9, similar numerals will be utilized to designate similar components, the suffix letter “b” being associated with the numerals of FIG. 10 to avoid confusion.

An inserter 20 b (FIG. 10) includes a handle (not shown) and a shaft 24 b which extends outward from the handle. The shaft 24 b is integrally formed from a single piece of metal, that is, stainless steel. The shaft 24 b includes a relatively large diameter main section 142 b and a relatively small diameter leading end section 144 b. The leading end section 144 b includes a positioning portion 146 b on which a conical point 76 b is disposed in a coaxial relationship with the main section 142 b of the shaft 24 b. An annular pusher surface 98 b is formed at the junction between the main section 142 b and positioning portion 146 b of the shaft 24 b.

In the illustrated embodiment of an anchor 32 b the anchor is a suture anchor. A suture 32 b has an outer leg 62 b which extends along the outside of the anchor 30 b. In addition, the suture 32 b has an inner leg 64 b which extends through a passage 28 b in the anchor 30 b. The leading end section 144 b and the inner leg 62 b of the suture 32 b both extend through the passage 28 b in the anchor 30 b.

In accordance with a feature of this embodiment of the invention, a spring 160 extends through a passage in the shaft 24 b. The illustrated spring 160 is formed of metal wire. However, the spring 160 could be a leaf spring formed of sheet metal if desired.

An upper end portion (not shown) of the wire spring 160 is connected with an actuator knob, corresponding to the actuator knobs 112 and 112 a of the embodiments of the invention illustrated in FIGS. 1–9. The spring 160 has a bent portion 164 which engages an inner side surface 52 b of the anchor 30 b.

After the anchor 30 b has been inserted into body tissue, in the manner described in conjunction with the embodiment of the invention illustrated in FIGS. 1–9, the spring 160 is axially tensioned. To axially tension the spring 160, the actuator knob is moved away from the leading end section 144 b of the shaft 24 b. The axial tension causes the bent portion 164 of the spring 160 to straighten and move out of engagement with the inner side surface 52 b of the passage 28 b in the anchor 30 b. The shaft 24 b can then be withdrawn from the anchor 30 b.

It is preferred to move the bent portion 164 of the spring 160 out of engagement with the inner side surface 52 b of the anchor 30 b by resiliently flexing the spring. However, the tension force applied to the spring 160 may only effect a reduction in the force applied by the spring against the inner side surface 52 b of the anchor 30 b.

In the embodiment of the invention illustrated in FIG. 10, the anchor 30 b and one-piece shaft 24 b are separated by merely withdrawing the shaft from the anchor after it has been positioned in a desired location in body tissue. However, a pusher member, corresponding to the pusher rod 150 of the embodiment of the invention illustrated in FIGS. 6–9 could be utilized to promote separation of the anchor 30 b from the shaft 24 b if desired. Alternatively, the shaft 24 b could be formed by two relatively movable members, corresponding to the inner and outer members 92 and 94 of the embodiment of the invention illustrated in FIGS. 1–5. Of course, the orientation of the anchor 30 b can be changed relative to the shaft 24 b by tensioning the leg 64 b of the suture 32 b as the point 76 b of the shaft 24 b moves to a location adjacent to the trailing end surface 42 b of the anchor.

Inserter—Fourth Embodiment

In the embodiments of the invention illustrated in FIGS. 1–10, the outer member 94 moves relative to the inner member 92 during positioning of an anchor relative to body tissue. In the embodiment of the invention illustrated in FIGS. 11–15, the inner member may move relative to the outer member. Since the embodiment of the invention illustrated in FIGS. 11–15 is generally similar to the embodiments of the invention illustrated in FIGS. 1–10, similar numerals will be utilized to identify similar components, the suffix letter “c” being added to the numerals of FIGS. 11–15 to avoid confusion.

An anchor inserter apparatus 20 c, constructed in accordance with the present invention, is illustrated in FIG. 11 and is used to position an anchor 30 c relative to body tissue. The illustrated anchor 30 a is a suture anchor. The apparatus 20 c includes a tubular outer member 94 c. The tubular outer member 94 c has a cylindrical tubular body 200 and a handle 22 c which are integrally formed as one piece.

An inner member 92 c is disposed in a passage 204 which is formed in the tubular outer member 94 c. The cylindrical passage 204 extends between a circular entrance opening 206 and a circular exit opening 208 formed in the tubular outer member 94 c. The inner member 92 c includes a cylindrical body 212. A circular handle 214 is integrally formed as one piece with the cylindrical body 212 of the inner member 92 c. The inner member 92 c has an axially tapered leading end portion 218 with a surface which applies force against a trailing end portion 48 c of the suture anchor 30 c.

The apparatus 20 c is illustrated in FIG. 11 in a fully assembled condition prior to use of the apparatus to position the anchor 30 c in either hard or soft body tissue. At this time, the trailing end portion 38 c of the suture anchor 30 c is disposed in the passage 204 in the tubular outer member 94 c. A leading end portion 44 c of the suture anchor 30 c extends outward from the tubular member 94 c.

In accordance with a feature of this embodiment of the invention, a slot 102 c (FIGS. 11 and 12) extends between the entrance opening 206 (FIG. 11) to the cylindrical passage 204 and the exit opening 208 from the passage. The slot 102 c extends through the handle 22 c. The slot 102 c is defined by a pair of flat parallel linear side surfaces 224 and 226 (FIGS. 11 and 12). The side surfaces 224 and 226 extend between a cylindrical outer side surface 228 (FIG. 12) on the tubular outer member 94 c and a cylindrical inner side surface 230 (FIG. 12) of the passage 204 in the tubular outer member.

When the inserter 20 c is used with a suture anchor, the slot 102 c facilitates positioning of the anchor 30 c in the passage 204 during assembly of the suture anchor inserter apparatus 20 c (FIG. 11). This is because outer and inner legs 62 c and 64 c of the suture 32 c can be readily positioned in the slot 102 c during assembly of the anchor inserter apparatus 20 c. The slot 102 c has a straight longitudinal central axis which extends parallel to the longitudinal central axis of the passage 204 and to a longitudinal central axis of the cylindrical body 212 of the inner member 92 c. The legs 62 c and 64 c of the suture 32 c extend between axially opposite ends of the slot 102 c. The slot 102 c encloses the suture 32 c and protects the legs 62 c and 64 c against being snagged by objects in the environment around the suture anchor inserter apparatus 20 c.

When the anchor inserter apparatus 20 c is to be assembled and used with a suture anchor, the suture 32 c (FIG. 11) is inserted through a pair of passages 236 and 238 in the suture anchor 30 c. The passages 236 and 238 extend diametrically through the suture anchor 30 c which, except for the passages 236 and 238, is a solid piece of material. A connector section 66 c (FIG. 13) of the suture extends between the passages 236 and 238. Although the illustrated anchor 30 c is formed from a solid cylindrical piece of stainless steel, the anchor 30 c could be formed of any one of many different materials and have any one of many different configurations, in the manner previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 1–5.

Once the suture 32 c (FIG. 11) has been threaded through the passages 236 and 238 in the suture anchor 30 c, the suture anchor is moved through the entrance opening 206 into the passage 204. The cylindrical body 212 of the inner member 92 c is then moved through the entrance opening 206 into the passage 204. The leading end portion 218 of the inner member 92 c moves into engagement with the trailing end portion 38 c of the anchor 30 c. The inner member 92 c is then used to push the anchor 30 c along the passage 204. Of course, if the anchor 30 c is not utilized to anchor the suture 32 c, the suture would be omitted.

In the illustrated embodiment of the invention, the tubular outer member 94 c is constructed with a passage 204 having an inside diameter which is less than the outside diameter of the anchor 30 c. This results in interference or drag between the anchor 30 c and the inner side surface 230 of the passage 204 in the tubular outer member 94 c.

The slot 102 c (FIG. 11) in the tubular outer member 94 c facilitates resilient flexing of the tubular outer member under the influence of force applied against the inner side surface 230 of the passage 204 by the anchor 30 c. The cylindrical body 212 of the inner member 92 c has an outside diameter which is less than the inside diameter of the passage 204. Therefore, there is no interference between the inner member 92 c and the outer member 94 c as the inner member 92 c is inserted into the passage 204. Of course, interference could be provided between the outer side surface on the body 212 of the inner member 92 c and the inner side surface 230 of the passage 204 if desired.

As the anchor 30 c moves along the passage 204 under the influence of force applied against the anchor by the inner member 92 c, the outer member 94 c is resiliently flexed and the width of the slot 102 c increases to accommodate the interference between the anchor 30 c and the inner side surface 230 of the passage 204. It should be understood that there is only a small amount interference between the anchor 30 c and the inner side surface 230 of the passage 204 in the tubular outer member so that the inner member 92 c can, with a relatively moderate amount of force, move the anchor 30 c along the passage 204.

The anchor 30 c is moved along the passage 204 to a position in which the trailing end portion of the anchor 30 c is disposed in the passage and the leading end portion 44 c of the suture anchor extends outward from the tubular outer member 94 c (FIG. 11). When the anchor 30 c moves to this position, the application of force to the inner member 92 c is interrupted. The interference between the outer side surface of the anchor 30 c and the inner side surface 230 of the passage 204 results in the tubular outer member 94 c gripping the outer side surface of the suture anchor 30 c. This gripping action enables the tubular outer member 94 c to hold the anchor 30 c against movement relative to the tubular outer member. This results in the anchor 30 c being maintained in the position shown in FIG. 11 during handling of the anchor inserter apparatus 20 c.

Once the anchor 30 c has been moved to the position shown in FIG. 11, the outer and inner legs 62 c and 64 c of the suture 32 c are moved into the slot 102 c and tensioned. The taut suture legs 62 c and 64 c are straight and have longitudinal central axes extending parallel to the longitudinal central axis of the slot 102 c and the passage 204 in the tubular outer member 94 c. The legs 62 c and 64 c of the suture 32 c extend through opposite ends of the slot 102 c. The suture legs 62 c and 64 c extend through the portion of the slot 102 c disposed in the handle 22 c. A suitable retainer, such as adhesive tape, may be utilized to secure the legs 62 c and 64 c to the cylindrical body 312 of the inner member 92 c and to retain the suture legs 62 c and 64 c in the slot 102 c. The resiliently deflected body 200 of the tubular outer member 94 c presses the cylindrical inner side surface 230 of the tubular outer member against the cylindrical outer side surface 50 c of the trailing end portion 38 c of the anchor 30 c to hold the anchor in place.

After the apparatus 20 c has been assembled, in the manner previously explained, the apparatus is transported from a remote assembly location to an operating room or other location where the apparatus is to be used to position the anchor 30 c in body tissue. The manner in which the suture anchor inserter apparatus 20 c is used to position the anchor 30 c in a recess or opening 250 formed in bone 252 is illustrated schematically in FIGS. 13–15. The bone 252 includes a hard outer layer 254 and soft cancellous inner bone 256.

When the anchor 30 c is to be positioned in the bone 252, the leading end portion 44 c (FIG. 11) of the anchor 30 c is inserted into the recess or opening 250. Since the leading end portion 44 c of the anchor 30 c extends outward from the tubular outer member 94 c, aligning of the anchor 30 c with the opening 254 in the bone 252 is facilitated. In addition, the presence of the slot 102 c enables a surgeon to visualize the position of the leading end portion 44 c of the anchor 30 c relative to the outer layer 254 of the bone 252 as the leading end portion 44 c of the anchor 30 c is inserted into the recess or opening 250 (FIGS. 11 and 13). During initial positioning of the anchor 30 c in the opening 250 in the bone 252, the tubular outer member 94 c grips the anchor and holds the anchor against movement relative to the tubular outer member.

Once the leading end portion 44 c of the anchor 30 c has been positioned in the opening 250, in the manner illustrated schematically in FIG. 13, the tubular outer member 94 c and inner member 92 c are moved relative to each other to move the anchor 30 c further into the opening 250. Thus, the inner member 92 c is moved downward (as viewed in FIG. 13) to push the trailing end portion 38 c (FIG. 11) of the anchor 30 c out of the passage 204 in the tubular outer member 94 c. As this occurs, the leading end portion 218 of the inner member 92 c moves out of the tubular outer member 94 c into the opening 250 (FIGS. 13 and 14).

When the anchor 30 c is a suture anchor, the legs 62 c and 64 c of the suture 32 c are tensioned to pivot or toggle the anchor relative to the leading end portion 218 of the inner member 92 c. This results in the anchor 30 c moving from an orientation in which a longitudinal central axis of the anchor 30 c is aligned with the longitudinal central axis of the tubular outer member 94 c (FIG. 13) to a position in which the longitudinal central axis of the anchor 30 c extends transverse to the longitudinal central axis of the tubular outer member 94 c. The leading end portion 318 of the inner member 92 c is tapered to promote the pivotal movement of the anchor 30 c in a manner similar to that disclosed in U.S. Pat. No. 5,403,348 issued Apr. 4, 1995 to Peter M. Bonutti and entitled “Suture Anchor”. However, as was previously mentioned, the anchor 30 c could remain in its initial orientation.

Once the anchor 30 c has been pivoted to the desired orientation relative to the bone 252, the inserter apparatus 20 c is withdrawn from the recess 250 and disengaged from the legs 62 c and 64 c of the suture 32 c. Disengagement of the anchor inserter apparatus 20 c from the suture 32 c is facilitated by the slot 102 c (FIG. 11) in the tubular outer member 94 c. Thus, when the anchor inserter apparatus 20 c is to be disengaged from the suture 32 c, it is merely necessary move the anchor inserter apparatus 20 c sidewardly away from the legs 62 c and 64 c of the suture 32 c or to pull the legs of the suture sidewardly away from the anchor inserter apparatus 20 c.

Once the tubular outer member 94 c and inner member 92 c have been disengaged from the suture 32 c, the anchor inserter apparatus 20 is sterilized. A suture anchor 30 c is then loaded into the anchor inserter apparatus 20 c and suture anchor inserter apparatus reused. The slot 102 c facilitates reloading of the anchor inserter apparatus 20 c.

Although the anchor inserter apparatus 20 c may be initially loaded or reloaded with a second anchor 30 c in the manner previously explained, it is believed that it may be preferred to load the anchor inserter apparatus 20 c by merely moving the trailing end portion 38 c of anchor 30 c through the exit opening 208 in the leading end portion 242 of the tubular outer member 94 c while the tubular inner member 92 c is withdrawn. The trailing end portion 38 c of the anchor 30 c can be manually inserted through the opening 208 in the leading end portion 242 of the tubular outer member 94 c. The trailing end portion 38 c of the anchor 30 c is rounded or chamfered to facilitate moving the trailing end portion 38 c of the anchor 30 c into the passage 204 in the tubular outer member 94 c.

As an anchor 30 c is manually moved into the leading end portion 242 of the tubular outer member 94 c, the trailing end portion 38 c of the anchor 30 c applies force against the exit opening 208 to resiliently deflect and expand the body 200 of the tubular outer member 94 c. As the body 200 of the tubular outer member 94 c is resiliently expanded, the width of the portion of the slot disposed in the leading end portion 242 of the tubular outer member 94 c is increased. This results in the inner side surface 230 of the passage 204 in the tubular outer member 94 c firmly gripping the trailing end portion 38 c of the anchor 30 c as the anchor is moved through the opening 208.

The tubular outer member 94 c and inner member 92 c may be formed of any desired material. For example, it is contemplated that the tubular outer member 94 c and handle 22 c could be fabricated from a single piece of metal sheet material. The inner member 92 c and handle 214 could be fabricated from a metal rod. Alternatively, the tubular outer member 94 c and handle 22 c could be integrally molded as one piece of polymeric material. Similarly, the inner member 92 c and handle 214 could be molded of a suitable polymeric material.

In the foregoing description of the manner in which the anchor 30 c is positioned relative to the bone 252, the anchor is moved out of the passage 204 in the tubular outer member 94 c by moving the inner member 92 c relative to the outer member 94 c. However, it is contemplated that the anchor 30 c could be separated from the tubular outer member 94 c by moving the tubular outer member relative to the inner member 92 c. Thus, the inner member 92 c could be maintained stationary and the outer member 94 c moved relative to the inner member. Although FIGS. 13–15 illustrate positioning the anchor 30 c relative to the bone 252, the anchor inserter apparatus 20 c could be used to position the anchor relative to soft body tissue.

In the embodiment of the invention illustrated in FIG. 11, the tubular outer member 94 c has a relatively simple flange-type handle 22 c and the inner member 92 c has a relatively simple handle 214. It is contemplated that the tubular outer member 94 c and the inner member 92 c could be provided with handles which are formed separately from the tubular outer member and the inner member. For example, the inner member 214 could be provided with a handle similar to the handle provided for the embodiment of the invention illustrated in FIG. 1.

Retainer

In the embodiment of the invention illustrated in FIGS. 11–15, the anchor 30 c is a suture anchor and the legs 62 c and 64 c of the suture 32 c are positioned in the open slot 102 c of the suture anchor inserter apparatus 20 c. In the embodiment of the invention illustrated in FIGS. 16–18, a retainer member is provided in association with the anchor inserter apparatus 20 c to hold the legs of the suture in the slot when the anchor is used with a suture. Since the embodiment of the invention illustrated in FIGS. 16–18 has a construction which is similar to the construction of the embodiment of the invention illustrated in FIGS. 11–15, similar numerals will be utilized to designate similar components, the suffix letter “d” being associated with the numerals of FIGS. 16–18 to avoid confusion.

The suture anchor inserter apparatus 20 d (FIG. 16) includes a tubular outer member 94 d having a cylindrical passage 204 d. A cylindrical inner member 92 d extends into the passage 204 d in the outer member 94 d. A straight slot 102 d is formed in the tubular outer member 94 d and extends between opposite ends of the tubular outer member 94 d. The slot 102 d forms a passage through a handle 22 d which is integrally formed as one piece with the tubular outer member 94 d.

In accordance with a feature of this embodiment of the invention, a suture retainer sleeve 270 is rotatably mounted on the tubular outer member 94 d. The suture retainer sleeve 370 has a generally cylindrical configuration. A slot 272 extends between axially opposite ends of the suture retainer sleeve 270. The suture retainer sleeve 270 spans the slot 102 d (FIGS. 16 and 17) to retain the legs 62 d and 64 d of the suture 32 d in the slot. Thus, the sleeve 270 holds the suture legs 62 d and 64 d in the slot 102 d with the suture legs extending between opposite ends of the slot.

When the anchor inserter apparatus 20 d is being assembled, the retainer sleeve 270 is rotated in a counterclockwise direction (as viewed in FIG. 17) relative to the tubular outer member 94 d to move the slot 272 in the retainer sleeve 270 into alignment with the slot 102 d of the tubular outer member 94. This enables the legs 62 d and 64 d of the suture 42 d to be positioned in the slot 102 d in the tubular outer member 94 d. Once the legs 62 d and 64 d have been positioned in the slot 102 d in the tubular outer member 94 d, in the manner illustrated in FIG. 18, the suture retainer sleeve 270 is rotated in a clockwise direction to again span the slot 102 d and block movement of the legs 62 d and 64 d of the suture 30 d out of the slot (FIG. 17).

In the embodiment of the invention illustrated in FIGS. 16–18, a cylindrical suture retainer sleeve or ring 270 is rotatably mounted on the tubular outer member 94 d and is movable between a closed position blocking the slot 102 d and an open position providing access to the slot 102 d. However, it is contemplated that any desired type of member could be mounted on the tubular outer member 94 d to block the slot 102 d and retain the suture 32 d in the slot. In the embodiment of the invention illustrated in FIGS. 16–18, the suture retainer sleeve 270 extends along only a portion of the length of the tubular outer member 94 d. If desired, the suture retainer sleeve 270 could have a substantially greater axial extent so as to span a greater axial length of the slot 102 d when the suture retainer sleeve 270 is in the closed position illustrated in FIG. 17.

The suture retainer sleeve 270 has been illustrated in FIG. 16 as being mounted on a suture anchor inserter apparatus 20 d having the same construction as the anchor inserter apparatus 20 c of FIGS. 11–15. However, the suture retainer sleeve 270 could be utilized in conjunction with the embodiment of the invention illustrated in FIGS. 1–5 if desired. If this was done, the suture retainer sleeve 270 would be mounted on the outer member 94.

Anchor Retainer

In the embodiments of the invention illustrated in FIGS. 11–18, the anchor 30 c is held against movement relative to the tubular outer member 94 c due to interference between the suture anchor 30 c and the inner side surface 230 of the passage 204 in the tubular outer member 94 c. In the embodiment of the invention illustrated in FIGS. 19–22, there is no interference between the anchor and the inner side surface of the tubular outer member throughout a major portion of the length of the tubular member. The leading end portion 242 (FIG. 11) of the tubular outer member 94 c is provided with a retainer which is effective to hold the anchor against movement. Since the embodiment of the invention illustrated in FIGS. 19–21 is generally similar to the embodiments of the invention illustrated in FIGS. 1–18, similar numerals will be utilized to designate similar components, the suffix letter “e” being associated with the numerals of FIGS. 20–22 to avoid confusion.

The anchor inserter apparatus 20 e has the same general construction as the anchor inserter apparatus 20 c of FIG. 11. The anchor inserter apparatus 20 e (FIG. 19) includes a tubular outer member 94 e having a slot 102 e. The slot 102 e extends between openings at axially opposite ends of the tubular outer member 94 c. Thus, the slot 102 e extends to an exit opening 208 e in the leading end portion 242 e of the tubular outer member 94 e.

An inner member 92 e (FIGS. 20–22) is telescopically received in a passage 204 e (FIGS. 21 and 22) in the tubular outer member 94 e. The cylindrical inner member 92 e has a diameter which is less than the diameter of the passage 204 e in the tubular outer member 94 e. The inner member 92 e has a leading end portion 218 e (FIGS. 20–22) which is engageable with a suture anchor 30 e.

The anchor 30 e (FIG. 20) is a suture anchor and has a pair of parallel passages 236 e and 238 e which extend diametrically through the anchor 30 e. A suture 32 e extends through the cylindrical passages 236 e and 238 e in the suture anchor 30 e. Thus, the suture 32 e has an outer leg 62 e which extends through the passage 238 e in the suture anchor 30 e. Similarly, the suture 32 e has an inner leg 64 e which extends through the passage 236 e in the suture anchor 30 e. A connector section 66 e (FIGS. 21 and 22) of the suture 32 e extends along an outer side surface of the suture anchor 30 e and interconnects the two legs 62 e and 64 e. The suture 32 e may be omitted if desired.

In accordance with a feature of this embodiment of the invention, an anchor retainer or positioner 280 is provided in the leading end portion 242 e of the tubular outer member 94 e to hold the anchor 30 e in a desired position relative to the tubular outer member. In the embodiment of the invention illustrated in FIGS. 19–22, the anchor retainer 280 is resiliently deflectable under the influence of force applied against the anchor retainer by a leading end portion 44 e of the suture anchor 30 e. The anchor retainer 280 then grips a cylindrical outer side surface 50 e of the anchor 30 e to hold the anchor against movement relative to the tubular outer member 94 e. The anchor 30 e may be a suture anchor

The tubular outer member 94 e is initially formed so that the inner side surface 230 e (FIG. 19) of the passage 204 e tapers axially outward and radially inward from a relatively large diameter upstream or ahead of the leading end portion 242 of the tubular outer member to a relatively small size at the axially outer end of the tubular outer member 94 e. Thus, the passage 204 e in the tubular outer member 94 e tapers axially toward the right (as viewed in FIG. 19) to the exit opening 208 e. The exit opening 208 e has a generally oval configuration formed by radially inwardly projecting end portions 284 and 286 of the tubular outer member 94 e.

The passage 204 e in the tubular outer member 94 e has a circular cross sectional configuration, as viewed in a plane extending perpendicular to the longitudinal central axis of the passage, throughout the length of the passage ahead of the leading end portion 242 e of the tubular outer member 94 e. This portion of the passage 204 e has a diameter which is slightly larger than the diameter of the suture anchor 30 e. At the leading end portion 242 e of the tubular outer member 94 e, the passage 240 e tapers inwardly (FIG. 21) to the opening 208 e. The opening 208 e has a cross sectional area, as viewed in a plane extending perpendicular to a longitudinal central axis of the passage 204 e, which is smaller than the cross sectional area of the portion of the passage 204 e ahead of the leading end portion 242 e of the tubular outer member 94 e and smaller than the cross sectional area of the anchor 30 e.

The slot 102 e in the tubular outer member 94 e (FIG. 19) has a uniform width throughout the length of the slot ahead of the leading end portion 242 e of the tubular outer member 94 e. At the leading end portion 242 e of the tubular outer member 94 e, the width of the slot 102 e decreases as the passage 240 e tapers inwardly to the opening 208 e. At the opening 208 e, the slot 102 e has a width which is smaller than the width of the slot 102 e ahead of the leading end portion of the tubular outer member 94 e.

Upon movement of the anchor 30 e through the leading end portion 242 e of the tubular outer member 94 e, the leading end portion 50 e of the anchor 30 e applies force against the outer end portion 242 e of the tubular outer member 94 e to resiliently deflect the end portions 284 and 286 of the tubular member 94 e radially outward. This results in the tubular outer member 94 e being resiliently expanded so that the passage 204 e is substantially the same size throughout the length of the passage. As the leading end portion 242 e of the tubular outer member 94 e is resiliently expanded, the width of the portion of the slot 102 e in the leading end portion of the tubular outer member increases. This results in the slot 102 e having a substantially uniform width throughout its length.

During assembly of the anchor inserter apparatus 20 e, the anchor 30 e is moved through an entrance opening, corresponding to the entrance opening 206 of FIG. 11, to the passage 204 e. The cylindrical outer side surface 50 e (FIG. 21) of the suture anchor 30 e has a diameter which is less than the diameter of the passage 204 e until the suture anchor moves to the leading end portion 242 e of the tubular outer member 94 e. Therefore, the anchor 30 e can be readily moved along the passage 204 e from an entrance opening to the radially inwardly tapering leading end portion 242 e of the tubular member 94 e under the influence of either gravity and/or force transmitted from the suture 32 e to the anchor 30 e.

When the leading end portion 44 e of the anchor 30 e encounters the inwardly tapering leading end portion 242 e of the tubular outer member 94 e (FIG. 21) continued movement of the anchor 30 e toward the right (as viewed in FIG. 21) is impeded. The inner member 92 e is then moved along the passage 204 e until the axially tapered leading end portion 218 e of the inner member engages a trailing end portion 38 e of the anchor 30 e. An axial force is then transmitted from the inner member 92 e to the trailing end portion 38 e of the anchor 30 e. This force presses the leading end portion 44 e of the anchor 30 e against the inwardly sloping end portions 284 and 286 (FIG. 19) of the tubular outer member 94 e at the axially tapering leading end portion of the passage 204 e.

The force applied against the inwardly projecting portions 284 and 286 of the tubular outer member 94 e by the leading end portion 44 e of the anchor 30 e resiliently expands the tubular outer member 94 e from the configuration illustrated in FIG. 21 to the configuration illustrated in FIG. 22. As this occurs, the axially tapering end portion of the passage 204 e in the leading end portion 242 e of the tubular outer member 94 e is resiliently expanded to a cylindrical configuration (FIG. 22). Once this has occurred, the anchor 30 e is gripped by the leading end portion 242 e of the tubular outer member 94 e.

The inner side surface 230 e (FIG. 22) of the passage 204 e through the tubular outer member 94 e is pressed firmly against the cylindrical outer side surface 50 e of the suture anchor 30 e. This enables the retainer 280 to securely hold the suture anchor in the position shown in FIG. 22. At this time the trailing end portion 38 e of the anchor 30 e is disposed in the passage 204 e and the leading end portion 44 e of the anchor 30 e extends outward from the tubular outer member 94 e.

After the specific anchor 30 e has been moved to the position shown in FIG. 22, the legs 62 e and 64 e of the suture 32 e are tensioned and positioned in the slot 102 e in the manner previously explained in conjunction with the embodiment of the invention illustrated in FIG. 11. The suture legs 62 e and 64 e extend through axially opposite end portions of the slot 102 e. A retainer sleeve, corresponding to the retainer sleeve 270 of FIGS. 16–18, may be provided in association with the tubular outer member 94 e of FIGS. 19–22 to retain the legs 62 e and 64 e of the suture 32 e in the slot 102 e in the manner previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 16–18. Alternatively, a retainer, such as adhesive tape, could be used to hold the suture legs 62 e and 64 e in the slot 102 e.

It should be understood that the tubular outer member 94 e is provided with a handle, corresponding to the handle 22 c of FIG. 11. The slot or passage 102 e extends through the handle on the tubular outer member 94 e in the same manner as previously described in conjunction with the embodiment of the invention illustrated in FIG. 11. The suture legs 62 e and 64 e extend through an open end of the slot 102 e in the handle to enable a surgeon to manually engage the suture legs. A handle, corresponding to the handle 214 of FIG. 11, may be provided in association with the inner member 92 e of FIGS. 20–22.

Once the anchor inserter apparatus 20 e has been assembled, in the manner previously described, the suture anchor inserter apparatus is used to position the anchor 30 e relative to body tissue. The anchor inserter apparatus 20 e is used to position the anchor 30 e relative to body tissue in the same manner previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 11–15. Once the anchor 30 e has been positioned relative to body tissue, the suture legs 62 e and 64 e are easily disengaged from the open slot 102 e in the tubular outer member 94 e.

In the embodiment of the invention illustrated in FIGS. 19–22, a single slot 102 e extends throughout the axial length of the tubular outer member 94 e to accommodate the legs 62 e and 64 e of the suture 32 e. If desired, the tubular outer member 94 e could be formed without the slot. If this was done, the outer end portion 242 e of the tubular outer member 94 e would still be axially tapered. In the absence of the slot 102 e, the legs 62 e and 64 e of the suture 32 e would be disposed in the passage 204 e and would be enclosed by the tubular outer member 94 e. However, the suture 32 e could be omitted if desired.

It is believed that it will be preferred to provide the slot 102 e in the tubular outer member 94 e in order to facilitate positioning of the legs 62 e and 64 e of the suture 32 e relative to the anchor inserter apparatus 20 e during assembly of the apparatus when the anchor is a suture anchor. In addition, the slot 102 e facilitates separating the anchor inserter apparatus 20 e from the suture 32 e after the suture anchor 30 e has been positioned in body tissue in the manner previously explained. Of course, the anchor 30 e could have any known construction.

In the embodiment of the invention illustrated in FIGS. 19–22, the slot 102 e extends throughout the axial extent of the tubular outer member 94 e. It is contemplated that one or more slots, which extend for a distance less than the axial extent of the tubular outer member 94 e, could be provided in the tubular outer member. For example, three slots could be provided at equally spaced intervals about the circumference of the tubular outer member 94 e. Each of these three slots may have a length which is approximately two to four times as great as the length of a suture anchor 30 e. If a plurality of slots with a length which is less than the axial extent of the tubular outer member 94 e are used, the portion of the tubular member between each of the slots may extend radially inward toward the central axis of the tubular outer member 94 e and be resiliently deflected by engagement with the leading end portion 44 e of the suture anchor 30 e.

In the embodiment of the invention illustrated in FIGS. 19–22, the tubular outer member 94 e is formed of metal and the anchor retainer 280 is formed by deflecting the edge portions 284 and 286 of the tubular outer member radially inward toward the central axis of the tubular outer member 94 e. It should be understood that the extent of deflection of the edge portion 286 is exaggerated in FIG. 21 in order to provide a clear schematic illustration of the manner in which the edge portions 284 and 286 are deflected. It is contemplated that the extent of deflection of the edge portions 284 and 286 will be less than has been illustrated in FIG. 21.

If desired, the tubular outer member 94 e could be molded as a single piece of polymeric material. If the tubular outer member 94 e is molded as single piece of polymeric material, the inwardly extending edge portions 284 and 286 would be formed in the tubular outer member 94 e as originally molded. The side wall of the tubular outer member 94 e would have sufficient flexibility to enable the edge portions 284 and 286 to be resiliently deflected under the influence of force applied against them by the leading end portion 44 e of the suture anchor 30 e.

In the embodiment of the invention illustrated in FIGS. 19–22, the inner member 92 e is moved toward the right (as viewed in FIGS. 21 and 22) relative to the tubular outer member 94 e. The force transmitted from the inner member 92 e to the anchor 30 e presses the leading end portion 44 e of the anchor against the deflected portions 284 and 286 of the tubular outer member 94 e. This cams or forces the deflected portions 284 and 286 radially outward as the anchor 30 e moves from the position shown in FIG. 21 to the position shown in FIG. 22. However, if desired, the tubular outer member 94 e could be moved relative to the inner member 92 e. Thus, the inner member 92 e could be maintained stationary in the position shown in FIG. 21. The tubular outer member 94 e would be moved toward the left (as viewed in FIG. 21) to effect relative movement between the inner and outer members 92 e and 94 e. As this relative movement occurs, the inwardly projecting edge portions 284 and 286 of the tubular outer member 94 e would be cammed or forced radially outward. Relative movement between the inner member 92 e and the tubular outer member 94 e would be interrupted when the tubular outer member had moved to the position illustrated in FIG. 22 relative to the inner member.

Retainer Recess

In the embodiment of the invention illustrated in FIGS. 19–22, the tubular outer member 94 e grips the cylindrical outer side surface 50 e of the suture anchor 30 e to hold the suture anchor in a desired position. In the embodiment of the invention illustrated in FIG. 23, the tubular outer member grips a recess formed in the suture anchor to hold the suture anchor in the desired position. Since the embodiment of the invention illustrated in FIG. 23 is generally similar to the embodiment of the invention illustrated in FIGS. 1–22, similar numerals will be utilized to designate similar components, the suffix letter “f” being associated with the numerals of FIG. 23 to avoid confusion.

The anchor inserter apparatus 20 f of FIG. 23 has the same general construction as the anchor inserter apparatus 20 c of FIG. 11. The anchor inserter apparatus 20 f (FIG. 23) includes a cylindrical tubular outer member 94 f having a slot 102 f. The straight slot 102 f extends between openings at axially opposite ends of the tubular outer member 94 f. Thus, the slot 102 f extends to an exit opening 208 f in the leading end portion of the tubular outer member 94 f.

A cylindrical inner member 92 f is telescopically received in a passage 204 f in the tubular outer member 94 f. The cylindrical inner member 94 f has a diameter which is less than the diameter of the passage 204 f in the tubular outer member 94 f. The inner member 92 f has a leading end portion which is engageable with the anchor 30 f.

In the embodiment illustrated in FIG. 23, the anchor 30 f has a tubular configuration. Thus, the anchor 30 f has a longitudinally extending central passage 28 f which extends between a trailing end portion 38 f and a leading end portion 44 f of the anchor 30 f.

Although the anchor 30 f could have many different constructions, the specific anchor illustrated in FIG. 23 is a suture anchor. Therefore, the anchor 30 f is used with a suture 32 f. The suture 32 f has outer and inner legs 62 f and 64 f which extend through passages 236 f and 238 f which extend radially through the suture anchor 30 f. The outer and inner legs 62 f and 64 f of the suture 30 f are interconnected by a connector section 66 f which extends along an outer side surface of the anchor 30 f.

In accordance with a feature of this embodiment of the invention, the anchor 30 f is provided with an annular recess or groove 300 (FIG. 23) which extends around the anchor 30 f and has a central axis which is coincident with a longitudinal central axis of the suture anchor. The annular recess or groove 300 extends radially inward from a cylindrical outer side surface 50 f of the anchor 30 f. The recess or groove 300 is disposed midway between the radial passages 236 f and 238 f which extend through the anchor 30 f. In the illustrated embodiment of the invention, the recess 380 has a gently curving configuration to avoid stress concentrations. However, the recess 300 could be more sharply defined if desired.

The tubular outer member 94 f has an annular projection 304 which extends radially inward from an inner side surface 230 f of the tubular outer member 94 f. The slot 102 f extends axially through the annular projection 304. The annular projection 304 has a central axis which is coincident with a longitudinal central axis of the tubular outer member 94 f and extends parallel to a longitudinal central axis of the slot 102 f. The portion of the passage 204 f ahead of the annular projection 304 has a diameter which is larger than the diameter of the trailing and leading end portions 38 f and 44 f of the anchor 30 f.

The annular projection 304 has an inside diameter which is less than the diameter of the trailing and leading end portions 38 f and 44 f of the anchor 30 f. Prior to engagement with the anchor 30 f, the annular projection 304 has an inside diameter which is slightly less than the outside diameter of the recess 300 in the suture anchor. This results in the annular projection 304 being deflected radially outward when the annular projection engages the recess 300 in the suture anchor 30 f. Therefore, the annular projection 304 firmly grips the anchor 30 f when the annular projection engages the recess 300 (FIG. 23).

When the annular projection 304 engages the recess 300, the trailing end portion 38 f of the anchor 30 f is disposed in a passage 204 f in the tubular outer member 94 f. The leading end portion 44 f of the anchor 30 f extends axially outward from the tubular outer member 94 f. The distance which the anchor 30 f extends outward from the tubular outer member 94 f is determined by the location of the annular projection 304 f relative to the axially outer end of the tubular outer member 94 f and the location of the annular recess relative to the leading end portion 44 f of the anchor 30 f.

When the anchor 30 f is to be moved to the position shown in FIG. 23, the anchor is positioned in the passage 204 f and moved along the passage until the leading end portion 44 f of anchor 30 f engages the annular projection 304. The inner member 92 f then applies force against the trailing end portion 38 f of the anchor 30 f to press the leading end portion 44 f of the anchor against the annular projection 304. Force transmitted from the leading end portion 44 f of the anchor 30 f to the annular projection 304 causes the tubular outer member 94 f to resiliently expand. This resilient expansion of the tubular member 94 f increases the inside diameter of the annular projection 304.

As the anchor 30 f continues to move toward the right (as viewed in FIG. 23), the annular projection 304 expands radially and moves into engagement with a cylindrical outer side surface 50 f of the anchor 30 f. At this time, the width of the slot 102 f will have increased from an initial width to accommodate the radial expansion of the annular projection 304. Continued axial movement of the inner member 92 f toward the right (as viewed in FIG. 23) moves the passage 238 f through the anchor 30 f past the annular projection 304. As this occurs, the annular projection 304 moves into engagement with the annular recess 300 in the suture anchor 30 f.

The annular projection 304 resiliently grips the outer side surface of the suture anchor 30 f. Sloping side surfaces on the projection 304 cooperate with sloping side surfaces on the recess 300 in the suture anchor 30 f to cam or force the suture anchor to a position in which the annular projection is centered in the annular recess in the suture anchor 30 f. As this occurs, the width of the slot 102 f decreases. The rightward (as viewed in FIG. 23) force applied by the inner member 92 f against the anchor 30 f is interrupted when the anchor 30 f has moved to the position shown in FIG. 23. At this time, the end portion 280 f of the tubular outer member 94 f is resiliently expanded and the slot 102 f has a width which is greater than its undeflected width.

In the embodiment of the invention illustrated in FIG. 23, both the recess 300 and projection 304 have an annular configuration. Therefore, the annular projection will engage the annular recess even if the anchor 30 f is rotated about its longitudinal central axis to a position offset from the position shown in FIG. 23. However, if desired, the recess 300 could extend for a distance less than the entire circumference of the suture anchor 30 f and the projection 304 could extend for a distance which is less than the entire circumference of the tubular outer member 94 f. For example, the recess 300 and the projection 304 could have a generally circular conical configuration if desired.

In the foregoing description, it has been assumed that the inner member 92 f is moved axially relative to the outer member 94 f to move the suture anchor 30 f to the position shown in FIG. 23. However, if desired, the tubular outer member 94 f could be moved relative to the inner member 92 f. Thus, the tubular outer member 94 f could be moved toward the left (as viewed in FIG. 23) relative to the inner member 92 f to effect engagement of the annular recess 300 on the anchor 30 f with the annular projection 304 on the tubular outer member 94 f.

In addition, the foregoing description has assumed that the anchor 30 f will be moved from the left toward the right relative to the tubular outer member 94 f in order to engage the annular projection 304. This assumes that the anchor 30 f will be inserted into the passage 204 f at an opening, corresponding to the opening 206 of FIG. 11, adjacent to a handle, corresponding to the handle 22 c of FIG. 11. However, if desired, the anchor 30 f could be inserted into the passage 204 f through the exit opening 208 f in the tubular outer member 94 f.

If the anchor 30 f is inserted into the passage 94 f through the exit opening 208 f, the trailing end portion 38 f of the anchor 30 f would be moved through the opening 208 f into engagement with the annular projection 304. An axially directed force would then be applied to the leading end portion 44 f of the anchor 30 f. This force would press the trailing end portion 38 f of the anchor 30 f against the annular projection 304. Force transmitted from the trailing end portion 38 f of the anchor 30 f would cause the annular projection 304 to expand with a resulting expansion of the slot 102 f. As this occurs, the projection 304 would move into engagement with the outer side surface 50 f of the anchor 30 f adjacent to the trailing end portion 38 f of the anchor.

The continued application of a leftward (as viewed in FIG. 23) force to the leading end portion of the anchor 30 f would move the trailing end portion 38 f of the suture anchor further into the passage 204 f. As this occurs, the annular projection 304 on the tubular outer member 94 f would move into engagement with the annular recess 300 in the anchor 30 f.

It is believed that the foregoing front end loading, that is movement of the anchor 30 f into the passage 204 f through the exit opening 208 f, may be preferred during assembly of the apparatus 20 f. This is because the anchor 30 f and tubular outer member 94 f are moved through a relatively short distance relative to each other to enable the annular projection 304 to engage the recess 300 in the anchor 30 f.

When the anchor 30 f is to be positioned in body tissue, the leading end portion 44 f of the anchor is inserted into the body tissue. Since the leading end portion 44 f of the anchor 30 f extends outward from the tubular outer member 94 f, locating the anchor in a desired position relative to body tissue is facilitated. In addition, the slot 102 f enables a surgeon to more easily visualize the position of the anchor 30 f relative to the body tissue. During initial positioning of the anchor 30 f relative to body tissue, the projection 304 grips the recess 300 to hold the anchor 30 f against movement relative to the tubular outer member 94 f. If desired, the suture 32 f could be omitted.

Once the leading end portion 44 f of the anchor 30 f has been initially positioned relative to the body tissue by is movement of the tubular outer member 94 f, the tubular outer member and inner member 92 f are moved relative to each other to move the anchor 30 f to a desired depth in the body tissue. Thus, the inner member 92 f is moved relative to the outer member 94 f to apply force against the trailing end portion 38 f of the anchor 30 f. This force is effective to resiliently expand the annular projection 304 and slot 102 f and move the anchor 30 f out of engagement with the annular projection and into body tissue. Alternatively, the inner member 92 f could be maintained stationary and the outer member 94 f moved relative to the inner member to move the anchor 30 f into the body tissue.

Once the anchor 30 f has been separated from the tubular outer member 94 f and moved to a desired depth in the body tissue, the orientation of the anchor may or may not be changed relative to the body tissue. When the anchor 30 f is associated with the suture 32 f, the legs 62 f and 64 f of the suture are tensioned to pivot the anchor. This results in the anchor moving from an orientation in which a longitudinal central axis of the anchor is aligned with a longitudinal central axis of the tubular outer member 94 f to an orientation in which the longitudinal central axis of the anchor extends transverse to the longitudinal central axis of the tubular outer member 92 f. The manner in which this is accomplished is the same as is disclosed in the aforementioned U.S. Pat. No. 5,403,348.

After the anchor 30 f has been positioned relative to body tissue, the suture 32 f is disengaged from the slot 102 f in the tubular outer member 94 f and handle (not shown). This is easily accomplished by moving the suture legs sideways out of the open slot 102 f.

In the embodiment of the invention illustrated in FIG. 23, the slot 102 f extends between axially opposite ends of the tubular outer member 94 f. If desired, one or more slots which extend only part way along the length of the tubular outer member 94 f could be provided. For example, three or four slots which extend from the exit opening 208 f a short distance past the annular projection 304 could be provided in the tubular outer member 94 f. These slots would enable the annular projection 304 to flex radially outward during relative movement between the suture anchor 30 f and the annular projection 304. It is also contemplated that the annular projection 304 could be constructed so as to be radially flexible without the provision of slots in the tubular outer member 94 f.

In the embodiment of the invention illustrated in FIG. 23, the annular projection 304 is integrally formed as one piece with the tubular outer member 94 f. It is contemplated that the annular projection 304 could be formed separately from the tubular outer member 94 f. For example, the annular projection 304 could be replaced by a resiliently expandable annular ring mounted in the passage 204 f in the tubular outer member 94 f. Alternatively, a resilient annular ring could be mounted on the outside of the tubular outer member 94 f and extend through chordal slots formed in the tubular outer member into the passage 204 f to engage the recess 300 in the anchor 30 f.

Anchor Retainer

In the embodiment of the invention illustrated in FIG. 23, the anchor retainer 280 f engages a recess 300 in the suture anchor 30 f. In the embodiment of the invention illustrated in FIGS. 24 and 25, an anchor retainer engages a passage in the anchor. A suture may extend through the passage. Since the embodiment of the invention illustrated in FIGS. 24 and 25 is generally similar to the embodiment of the invention illustrated in FIGS. 1–23, similar numerals will be utilized to designate similar components, the suffix letter “g” being associated with the numerals of FIGS. 24 and 25 to avoid confusion.

An anchor inserter apparatus 20 g has the same general construction as the anchor inserter apparatus 20 c of FIG. 11. Thus, the anchor inserter apparatus 20 g includes a tubular outer member 94 g having a passage 204 g which extends between an exit opening 208 g at a leading end portion 242 g of the tubular outer member 94 g and an entrance opening (not shown) at the opposite end of the tubular outer member 94 g. A straight slot 102 g extends between axially opposite ends of the tubular outer member 94 g. An inner member, not shown, corresponding to the inner member 92 c of FIG. 11, is axially movable in the passage 204 g.

In accordance with a feature of this embodiment of the invention, an anchor retainer 280 g (FIG. 24) is engageable with a passage 236 g which forms a recess in an anchor 30 g (FIG. 25). In the illustrated embodiment of FIGS. 24 and 25, a suture 32 g has an inner leg 64 g which extends through the passage 236 g to a connector section 66 g of the suture. The anchor 30 g has the same general construction as the suture anchor 30 f of FIG. 23. However, the anchor 30 g (FIG. 25) does not have an annular recess corresponding to the recess 300 in the anchor 30 f of FIG. 23.

The retainer 280 g (FIGS. 24 and 25) has a circular, generally hemispherical-shaped, projection 304 g which extends radially inward from an inner side surface 230 g of the passage 204 g in the tubular outer member 94 g. The projection 304 g is formed by indenting the outside of the tubular outer member 94 g. The hemispherical projection 304 g has a maximum diameter which is greater than the diameter of the passage 236 g (FIG. 25) which extends radially through the suture anchor 30 g. The projection 304 g is disposed diametrically opposite from the slot 102 g (FIG. 24).

The projection 304 g extends through an open end 310 (FIG. 25) of the passage 236 g which forms a recess in the anchor 30 g. The projection 304 g engages the open end portion 310 of the passage 236 g to hold the anchor 30 g against axial movement relative to the tubular outer member 94 g (FIG. 25). The projection 304 g presses the leg 64 g of the suture 32 g against the open end 310 of the passage 236 g to hold the suture 32 g against movement relative to the anchor 30 g. The projection 304 g also presses a portion of a cylindrical outer side surface 50 g on the anchor 30 g against a portion of the inner side surface 230 g of the passage 204 g adjacent to the slot 102 g (FIG. 24). If desired, a closed ended recess could be substituted for the open ended recess formed by the passage 236 g and the suture 32 g omitted.

When the anchor 30 g is to be inserted into the anchor inserter apparatus 20 g with the suture 32 g connected with the anchor, the anchor may be moved through an entrance opening, corresponding to the entrance opening 206 of FIG. 11, and into the passage 204 g. The anchor 30 g is moved along the passage 204 g until the leading end portion (not shown) of the anchor 30 g engages the projection 304 g.

An inner member, corresponding to the inner member 92 c of FIG. 11, then applies an axial force against the trailing end portion 38 g of the anchor 30 g. This causes the leading end portion of the anchor 30 g to cam or force the projection 304 g radially outward. As the projection 304 g is forced radially outward by the anchor 30 g, the width of a portion of the slot 102 g (FIG. 24) in the end portion 242 g of the tubular outer member 94 g increases and the end portion of the tubular outer member is resiliently expanded.

Continued rightward (as viewed in FIGS. 24 and 25) movement of the anchor 30 g (FIG. 25) relative to the tubular outer member 94 g moves the projection 304 g into alignment with a leading passage through the anchor 30 g, that is into alignment with a passage corresponding to the passage 238 f in the anchor 30 f of FIG. 23. If desired, the anchor 30 g could be positioned relative to the tubular outer member 94 g with the projection 304 g engaging the leading passage, that is the passage corresponding to the passage 238 f of FIG. 23, in the suture anchor 30 g. However, it is believed that it will be preferred to have the anchor 30 g extend further outward from the tubular outer member 94 g. Therefore, the application of force against the trailing end portion 38 g of the anchor 30 g by the inner member, corresponding to the member 92 c of FIG. 11, is continued.

The continued application of force to the trailing end portion 38 g of the anchor 30 g disengages the projection 304 g from the leading passage through the anchor 30 g. Continued rightward (as viewed in FIG. 25) axial movement of the anchor 30 g moves the projection 304 g into alignment with the passage 236 g in the anchor 30 g. When the projection 304 g snaps into the open end portion 310 of the passage 236 g, the application of force to the trailing end portion 38 g of the anchor 30 g is interrupted. At this time, the anchor 30 g is held against movement relative to the tubular outer member 94 g by engagement of the projection 304 g with the open end portion 310 of the passage 236 g.

The foregoing explanation has assumed that the anchor 30 g is moved into the passage 204 g at the entrance opening, corresponding to the entrance opening 206 of FIG. 11. However, the anchor 30 g could be moved into the passage 204 g through the exit opening 208 g if desired. When the anchor 30 g is inserted through the exit opening 208 g, the trailing end portion 38 g of the anchor 30 g moves into engagement with the projection 304 g. Continued leftward (as viewed in FIG. 25) movement of the anchor 30 g resiliently deflects the projection 304 g. As this occurs, the width of the slot 102 g increases.

As the anchor 30 g continues to move toward the left (as viewed in FIG. 25) relative to the projection 304 g, the projection engages the outer side surface 50 g of the anchor 30 g and slides along the outer side surface. Continued leftward movement of the anchor 30 g relative to the projection 304 g results in the projection moving into engagement with the open end portion 310 of the passage 236 g through the suture anchor 30 g. Once this occurs, the anchor 30 g is held against axial movement relative to the tubular outer member 94 g.

After the anchor inserter apparatus 20 g has been assembled, in the manner previously described, the apparatus is used to position the anchor 30 g relative to body tissue in the same manner as previously described in conjunction with FIGS. 13–15. After the anchor 30 g has been positioned relative to an opening in bone or other body tissue, in the manner illustrated in FIG. 13, the inner member is moved relative to the tubular outer member 94 g. The force applied against the trailing end 38 g of the anchor 30 g disengages the anchor from the projection 304 g.

Continued relative movement between the inner member and tubular outer member 94 g moves the anchor 30 g out of the passage 204 g in the tubular outer member. When the anchor 30 g has moved to the desired depth into the body tissue, the orientation of the anchor may be changed by tensioning the legs of the suture 32 g. This pivots or toggles the anchor 30 g in the same manner as previously described in conjunction with FIGS. 14 and 15.

The anchor 30 g illustrated in FIG. 25 has the same tubular construction as the anchor 30 f of FIG. 23. However, the anchor 30 g could have the solid cylindrical construction of the suture anchor 30 e of FIGS. 21 and 22 if desired. In fact, the anchor 30 g could have any desired construction. For example, the anchor 30 g could have a polygonal construction similar to that in the aforementioned U.S. Pat. No. 5,549,630. Alternatively, the anchor could have any one of the constructions illustrated in the aforementioned U.S. Pat. No. 5,403,348.

In the embodiment of the invention illustrated in FIGS. 24 and 25, the projection 304 g is integrally formed as one piece with the tubular outer member 94 g. However, it is contemplated that the projection 304 g could be formed separately from the tubular outer member 94 g. For example, the projection 304 g could be provided by a spring loaded plunger.

The use of such a spring loaded plunger would eliminate the necessity of resiliently deflecting the tubular outer member 94 b as the projection 304 g moves into engagement with a anchor 30 g. This would enable the slot 102 g to be eliminated. However, it is believed that it will be preferred to retain the slot 102 g in the tubular outer member 94 g to facilitate positioning of the suture 32 g relative to the tubular outer member during assembly and to facilitate disengagement of the tubular outer member 94 g from the suture after the suture anchor 30 g has been positioned relative to body tissue in the manner explained in conjunction with FIGS. 13 through 15. Of course, if the suture 32 is omitted, the slot 102 g could be omitted.

Suture Anchor Retainer—Plural Projections

In the embodiment of the invention illustrated in FIGS. 24 and 25, the anchor retainer 280 g includes a single projection 304 g which engages an open end portion 310 of the passage 236 g formed in the anchor 30 g. In the embodiment of the invention illustrated in FIGS. 26 and 27, a plurality of projections are provided to engage the open ends of a plurality of passages or recesses in an anchor. Since the embodiment of the invention illustrated in FIGS. 26 and 27 is generally similar to the embodiment of the invention illustrated in FIGS. 1–25, similar numerals will be utilized to designate similar components, the suffix letter “h” being associated with the numerals of FIGS. 26 and 27 to avoid confusion.

An anchor insertion apparatus 20 h (FIG. 26) includes a tubular outer member 94 h having a passage 204 h with an exit opening 208 h. A slot 102 h extends between axially opposite ends of the tubular outer member 94 h in the same manner as previously explained in conjunction with the embodiment of the invention illustrated in FIG. 11. The anchor inserter apparatus 20 h has the same general construction as the anchor inserter apparatus 20 c of FIG. 11.

In accordance with a feature of this embodiment of the invention, an anchor retainer 280 h includes a pair of identical projections 320 and 322. The projections 320 and 322 have the same generally hemispherical configuration as the projection 304 g of FIGS. 24 and 25. The two projections 320 and 322 are disposed diametrically opposite from the slot 102 h. The two projections 320 and 322 are integrally formed as one piece with the tubular outer member 94 h by indenting the tubular outer member.

The two projections 320 and 322 engage open ends of passages 236 h and 238 h in the same manner as in which the single projection 304 g of FIGS. 24 and 25 engages the open end portion 310 of the passage 236 g (FIG. 25). Thus, the projection 320 engages an open end portion 324 of the passage 236 h. Similarly, the projection 322 engages an open end portion 326 of the passage 238 h (FIG. 27). If desired, closed ended recesses could be substituted for the open ended recesses formed by the passages 236 h and 238 h.

The suture 32 h has outer and inner legs 62 h and 64 h which extend through the passages 236 h and 238 h. The projections 320 and 322 extend into the open end portions 324 and 326 of the passages 236 h and 238 h and press the suture legs 62 h and 64 h against the open end portions of the passages. A connector section 66 h extends between the open end portions 324 and 326 of the passages 236 h and 238 h. The two projections 320 and 322 press a portion of an outer side surface 50 h on the anchor 30 h against a portion of an inner side surface 230 g of the passage 204 h adjacent to the slot 102 h. If desired, the suture 32 h could be omitted.

When the anchor inserter apparatus 20 h is to be assembled, the anchor 30 h may be inserted through the entrance opening, corresponding to the entrance opening 206 of FIG. 11, into the passage 204 h (FIGS. 26 and 27). The anchor 30 h is then moved axially along the passage 200 h until a leading end portion 44 h of the anchor engages the projection 320.

An inner member, corresponding to the inner member 92 c of FIG. 11, applies force against a trailing end portion 38 h of the anchor 30 h. This force is transmitted from the leading end portion 44 h of the anchor 30 h to the projection 320 (FIG. 27). The force applied against the projection 320 resiliently deflects the tubular outer member 94 h. As this occurs, the width of the slot 102 h increases.

As the anchor 30 h continues to move forward, that is toward the right as viewed in FIG. 27, the open end portion 326 of the leading passage 230 h through the anchor 30 h moves into alignment with the projection 320. As this occurs, the projection 320 snaps into the open end portion 326 of the passage 238 h. Continued application of force to the trailing end portion 38 h of the anchor 30 h continues to move the anchor toward the right (as viewed in FIG. 27). As this occurs, the projection 320 becomes disengaged from the open end portion 326 of the passage 238 h and the anchor moves toward the position shown in FIG. 27.

As the anchor moves into the position shown in FIG. 27, the projection 322 snaps into the open end portion 326 of the passage 238 h. At the same time, the projection 320 snaps into the open end portion 324 of the passage 236 h. This results in the anchor 30 h being held in place by engagement of the projections 320 and 322 in the anchor 30 h.

In the foregoing explanation, the anchor 30 h was moved from the entrance opening rightward (as viewed in FIG. 27) toward the exit opening 208 h from the passage 204 h. It is contemplated that the anchor 30 h could be inserted into the passage 204 h in the tubular outer member 94 h through the exit opening 208 h. This would eliminate the necessity of moving the anchor 30 h through a relatively long distance along the passage 204 h.

The anchor inserter apparatus 20 h is used to position the anchor 30 h (FIG. 27) relative to body tissue in the same manner as previously explained in conjunction with the embodiments of the invention illustrated in FIGS. 1–25. Thus, an inner member, corresponding to the inner member 92 c of FIG. 11, is moved relative to the outer member 94 h. The force applied against the trailing end portion 38 h of the suture anchor 30 h resiliently deflects both of the projections 320 and 322 outwardly away from the slot 102 f to disengage the projections from the open end portions 324 and 326 of the passages 236 h and 238 h. As this occurs, the width of the slot 102 h increases.

As the anchor 30 h moves axially outward from the position shown in FIG. 27, the suture passage 238 in the suture anchor 30 h moves out of the passage 204 h in the tubular outer member 94 h. As this occurs, the projection 322 resiliently snaps into the open end portion 324 of the suture passage 236 h in the anchor 30 h. The continued application of force against the trailing end portion 38 h of the anchor 30 h by the inner member (not shown) again resiliently deflects the projection 322 to disengage the projection 322 from the open end portion 324 of the suture passage 236 h.

Continued movement of the inner member relative to the tubular outer member 94 h separates the anchor 30 h from the tubular outer member. When the anchor 30 h has been moved to a desired position relative to the body tissue, the suture anchor may be pivoted to change its orientation in the manner disclosed in the aforementioned U.S. Pat. No. 5,403,348. The inner member and the tubular outer member 94 h are then disengaged from the body tissue. The suture legs 62 h and 64 h can be easily disengaged from the open slot 102 h.

The foregoing description has assumed that positioning of the anchor 30 h relative to body tissue is to be accomplished by moving the inner member relative to the tubular outer member 94 h. However, if desired, the inner member could be held stationary relative to the body tissue and the tubular outer member 94 h moved relative to the inner member to separate the anchor 30 h from the tubular outer member.

Anchor Retainer Spring

In the embodiment of the invention illustrated in FIGS. 23–27, projections integrally formed with the tubular outer member have been utilized to retain the anchor in a desired position relative to the tubular outer member. In the embodiment of the invention illustrated in FIG. 28, a separate spring member is utilized to retain an anchor in a desired position relative to the tubular outer member. Since the embodiment of the invention illustrated in FIG. 28 is generally similar to the embodiment of the invention illustrated in FIGS. 11–27, similar numerals will be utilized to designate similar components, the suffix letter “j” being associated with the numerals of FIG. 28 to avoid confusion.

In the embodiment of the invention illustrated in FIG. 28, the anchor inserter apparatus 20 j has the same general construction as the anchor inserter apparatus 20 c of FIG. 11. The anchor inserter apparatus 20 j of FIG. 28 includes a cylindrical tubular outer member 94 j and a cylindrical inner member 92 j. An anchor retainer 280 j retains an anchor 30 j in a cylindrical passage 204 j which extends axially through the tubular outer member 94 j. The specific anchor 30 j illustrated in FIG. 28 is a suture anchor.

A suture 32 j is connected with the suture anchor 30 j. The suture 32 j has outer and inner legs 62 j and 64 j. The legs 62 j and 64 j of the suture 32 j are disposed in a slot 102 j which extends between axially opposite ends of the tubular outer member 94 j. If the suture 32 j is omitted, the slot 102 j could be omitted.

In accordance with a feature of this embodiment of the invention, the anchor retainer 280 j includes a spring 330 which is disposed in a recess or slot 332 formed in the tubular outer member 94 j opposite from the slot 102 j. The spring 330 has a projection 336 which extends through an open end portion 310 j of a passage 236 j in the anchor 30 j. Engagement of the projection 336 on the spring 330 with the open end portion 310 j of the passage 236 j holds the anchor 30 j against movement relative to the tubular outer member 94 j. The spring 330 is fixedly connected to the tubular outer member 94 j.

When the anchor 30 j is to be positioned in the anchor inserter apparatus 20 j, the anchor 30 j is inserted through an entrance opening to the passage 204 j. Thus, the anchor 30 j is inserted through an opening corresponding to the opening 206 of FIG. 11 adjacent to a handle portion of the anchor inserter apparatus 20 j. The anchor 30 j is moved along the passage 204 j until a leading end portion 44 j engages the projection 236 on the spring 330.

The inner member 92 j then applies force against a trailing end portion 38 j of the anchor 30 j. Force is transmitted from the leading end portion 44 j of the anchor 30 j to the projection 336 to resiliently deflect the spring 330 radially outward, that is downward as viewed in FIG. 28. This results in the spring 330 being moved into the slot 332 in the tubular outer member 94 j. In this embodiment of the invention, the width of the slot 102 j remains constant as the anchor 30 j moves into and/or out of the tubular outer member 94 j.

Continued movement of the anchor 30 j toward the exit opening 208 j results in the projection 336 engaging a cylindrical outer side surface 50 j on the anchor 30 j adjacent to the leading end portion 44 j of the suture anchor. As the rightward (as viewed in FIG. 28) movement of the anchor 30 j continues, the projection 336 on the spring 330 snaps into an open end portion of the passage 238 j in the anchor.

Continued movement of the inner member 92 j and anchor 30 j toward the right (as viewed in FIG. 28) relative to the tubular outer member 94 j results in the spring projection 336 moving out of engagement with the passage 238 j and into engagement with the cylindrical outer side surface 50 j of the anchor 30 j at a location between the two passages 236 j and 238 j. As the rightward movement of the anchor 30 j continues, the spring projection 336 snaps into the passage 236 j in the anchor 30 j in the manner illustrated schematically in FIG. 28. When this occurs, the application of force to the inner member 92 j is interrupted. This results in the anchor 30 j being held in place with the trailing end portion 38 j disposed in the passage 204 j and the leading end portion 44 j of the anchor 30 j extending outward from the tubular outer member 94 j.

In the embodiment of the invention illustrated in FIG. 28, the anchor 30 j is formed from a solid cylindrical piece of material. The two radially extending passages 236 j and 238 j are formed in the solid piece of cylindrical material. However, if desired, the suture anchor 30 j could be formed with the tubular configuration illustrated in FIGS. 23, 25 and 27. Rather than engaging the open end recess formed by the passage 236 j, the spring 330 could engage a closed end recess formed in the suture anchor 30 j at a location offset from the passages 236 j and 238 j. It is contemplated that the suture anchor 30 j could have any desired configuration and could be used either with or without the suture 32 j.

If desired, the anchor 30 j could be inserted into the passage 204 j through the opening 208 j. This would eliminate engagement of the spring 300 with the anchor passage 238 j during positioning of the anchor 30 j in the suture anchor retainer 280 j.

In the embodiment of the invention illustrated in FIG. 28, the slot 102 j extends between axially opposite ends of the tubular outer member 94 j. It is contemplated that the slot 102 j could be eliminated or that the slot could extend from the exit opening 208 j through a distance which is shorter than the axial extent of the tubular outer member 94 j. However, it is believed that it may be preferred to have the slot 102 j extend between axially opposite ends of the tubular outer member 94 j to facilitate positioning of the outer and inner suture legs 62 j and 64 j relative to the tubular outer member 94 j. In addition, by having the slot 102 j extend between axially opposite ends of the outer member 94 j, disengagement of the suture 32 j from the tubular outer member is facilitated after the anchor 30 j has been positioned relative to body tissue. Of course, if the suture 32 j is omitted, the slot 102 j could be omitted.

It is contemplated that the anchor 30 j will be positioned relative to body tissue in the same manner illustrated schematically in FIGS. 13–15. However, it should be understood that the anchor 30 j could be positioned relative to body tissue in a different manner if desired. It should be understood that the anchor inserter apparatus 20 j could be utilized to position the anchor 30 j relative to either hard body tissue, such as bone, or soft body tissue, such as a patient's skin or internal organs.

Anchor Retainer on Inner Member

In the embodiment of the invention illustrated in FIGS. 19–28, an anchor retainer has been disposed on a tubular outer member to retain the anchor against relative movement relative to the tubular outer member. In the embodiment of the invention illustrated in FIG. 29, an anchor retainer is disposed on an inner member to retain the anchor against movement relative to the inner member. Since the embodiment of the invention illustrated in FIG. 29 is generally similar to the embodiment of the invention illustrated in FIGS. 1–28, similar numerals will be utilized to designate similar components, the suffix letter “k” being associated with the numerals of FIG. 29 to avoid confusion.

An anchor inserter apparatus 20 k includes an inner member 92 k (FIG. 29) which is fixedly connected with a handle (not shown) in the same manner as previously described in connection with the embodiment of the invention illustrated in FIGS. 1–3. A tubular outer member 94 k, is axially slidable along the inner member 92 k. A slot 102 k extends between axially opposite ends of the outer member 94 k and is axially aligned with a corresponding slot in the handle portion of the suture anchor inserter apparatus 20 k. An anchor 30 k is disposed on the axially outer end portion of the inner member 92 k adjacent to a point 76 k on the inner member 92 k.

In accordance with a feature of this embodiment of the invention, an anchor retainer 280 k is mounted on the inner member 92 k to hold the anchor 30 k in a desired position relative to the anchor inserter apparatus 20 k. The anchor 30 k includes a pair of radially extending passages 236 k and 238 k which extend diametrically through the anchor 30 k. The passages 236 k and 238 k have a cylindrical configuration. The anchor 30 k has a tubular configuration with a central passage 28 k which is intersected by the suture passages 236 k and 238 k.

In accordance with a feature of the present invention, a spring 342 is mounted in a slot 344 in the inner member 92 k. The spring 342 has a projection 346 which engages an inner end portion 348 of the passage 238 k. The projection 346 extends into the passage 338 k and holds the suture anchor 30 k against movement relative to the inner member 92 k. The spring 342 has an end portion 350 which is fixedly connected with the inner member 92 k.

When the anchor 30 k is to be positioned on the inner member 92 k, the cylindrical axial passage 28 k through the anchor 30 k is aligned with the longitudinal central axis of the inner member 92 k and the point 76 k. At this time, the suture 32 k may be connected with the anchor 30 k. Thus, the outer leg 62 k of the suture 32 k extends through the radial passage 238 k in the anchor 30 k. Similarly, the inner leg 64 k extends through the passage 236 k in the anchor 30 k. A connector section 66 k interconnects the two legs 62 k and 64 k of the suture 32 k.

As the trailing end portion 38 k of the anchor 30 k is moved past the point 76 k and onto the cylindrical body of the inner member 92 k, the trailing end portion 38 k of the anchor 30 k engages the projection 346 on the spring 342. The axial force applied against the spring 342 by the trailing end portion 38 k of the anchor 30 k deflects the spring 342 into the slot 344. The projection 346 on the spring 342 then engages the open end portion 354 of the passage 236 k.

Continued application of force against the anchor 30 k results in the spring 342 again being deflected into the slot 344. As the anchor 30 k continues to move onto the inner member 92 k, the projection 346 on the spring 342 snaps into the open end portion 348 of the passage 238 k. This holds the anchor in the position shown in FIG. 29.

Once the anchor 30 k has been positioned on the outer end portion of the inner member 92 k, in the manner illustrated in FIG. 29, the outer and inner legs 62 k and 64 k of the suture 32 k may be positioned in the slot 102 k in the tubular outer member 94 k. The legs 62 k and 64 k of the suture 32 k are also positioned in a slot in the handle of the anchor inserter apparatus. The slot (not shown) in the handle of the anchor inserter apparatus 20 k is aligned with the slot 102 k in the tubular outer member 94 k.

Once the anchor 30 k has been positioned on the outer end portion of the inner member 92 k, the point 76 k of the outer member 92 k may be utilized to pierce relatively soft body tissue. The anchor 30 k is then separated from the inner member 92 k and moved into the body tissue by movement of the tubular outer member 94 k axially outward along the inner member 92 k. The orientation of the anchor 30 k is then changed in the same manner as explained in conjunction with the embodiment of the invention illustrated in FIGS. 1–3.

In the embodiment of the invention illustrated in FIG. 29, the spring 342 has a single projection 346 which engages the inner open end portion 348 of the passage 238 k in the anchor 30 k. If desired, the projection on the spring could engage the inner open end portion 354 of the passage 236 k on the anchor 30 k. If this was to be done, the orientation of the spring 242 in the slot 344 would be changed by 180 so that the projection 346 would be adjacent to the left (as viewed in FIG. 29) end of the slot 344 while the end 350 of the spring would be adjacent to the right end of the slot 344. Alternatively, the spring 342 could be provided with two projections to engage each of the passages 236 k and 238 k.

Anchor Retainer

In the embodiment of the invention illustrated in FIGS. 19–22, the anchor retainer 280 projects radially inward from one side of the tubular outer member 94 e (FIG. 19). In the embodiment of the invention illustrated in FIG. 30, the anchor retainer has an annular configuration and extends inward from the cylindrical side wall of the tubular outer member for the same distance throughout the extent of the tubular side wall. Since the embodiment of the invention illustrated in FIG. 30 is generally similar to the embodiment of the invention illustrated in FIGS. 1–29, similar numerals will be utilized to designate similar components, the suffix letter “m” being associated with the numerals of FIG. 30 to avoid confusion.

An anchor inserter apparatus 20 m includes a cylindrical tubular outer member 94 m and a cylindrical inner member 92 m which are disposed in a coaxial relationship. In accordance with a feature of this embodiment of the invention, an anchor retainer 280 m is provided at one end, that is, the right end as viewed in FIG. 30, of the tubular outer member 94 m. The anchor retainer 280 m has an annular configuration.

The annular retainer 280 m has an axially inner end portion 360 which is connected to a tubular cylindrical body 200 m of the tubular outer member 94 m. The retainer 280 m has an axially outer end portion 362 which defines a circular exit opening 208 m having a central axis which is coincident with a longitudinal central axis of the cylindrical body 200 m of the tubular outer member 94 m. The anchor retainer 280 m has an annular inner side surface 364 which tapers radially inward and axially outward. Although the anchor retainer 280 m has been illustrated in FIG. 30 as having a plurality of slots to facilitate flexing of the anchor retainer, the slots could be omitted if desired.

When the anchor 30 m is to be positioned in the anchor inserter apparatus 20 m, the suture anchor 30 m is moved through an opening at an end of the tubular outer member 94 m opposite from the exit opening 208 m. Thus, the anchor 30 m is moved through an opening corresponding to the entrance opening 206 adjacent to the handle 22 c of the embodiment of the invention illustrated in FIG. 11. At this time, the suture 32 m may be connected with the anchor 30 m. Thus, an outer leg 62 m of the suture 32 m extends through a passage 236 m formed in the suture anchor 30 m. Similarly, the inner leg 64 m of the suture 32 m extends through a passage 238 m formed in the suture anchor 30 m. The two legs 62 m and 64 m of the suture 32 m are interconnected by a connector section 66 m.

In the embodiment of the invention illustrated in FIG. 30, the tubular outer member 94 m has a continuous cylindrical outer side surface. Thus, a slot, corresponding to the slot 102 c of FIG. 11, is not formed in the tubular outer member 20 m. Therefore, the outer and inner legs 62 m and 64 m of the suture 32 m are received in a cylindrical passage 204 m formed in the tubular outer member 94 m. The suture legs 62 m and 64 m extend along an outer side surface of the cylindrical inner member 92 m. Of course, if desired, a slot corresponding to the slot 102 c of FIG. 11 could be formed in the tubular outer member 94 m. If desired, the anchor 30 m could be designed for use without the suture 32 m.

The pusher member 92 m moves the anchor 30 m forward, that is toward the right as viewed in FIG. 30, until a leading end portion 44 m of the anchor 30 m engages the inwardly tapering or sloping side surface 364 of the anchor retainer 280 m. When this occurs, the force applied by the inner member 92 m against the trailing end portion 38 m of the anchor 30 m is increased. This increased force deflects the annular anchor retainer 280 m radially and axially outward and increases the diameter of the exit opening 208 m. Thus, force applied by the leading end portion 44 m of the anchor 30 m against the slotted annular surface 364 flexes sections 370 radially outward away from the longitudinal central axis of the tubular outer member 94 m. As this occurs, the width of slots 372 between the sections 380 increases.

As the anchor 30 m is moved toward the right (as viewed in FIG. 30) by the inner member 92 m relative to the outer member 94 m, the sections 370 of the suture anchor retainer 280 m move into engagement with a cylindrical outer side surface 50 m on the suture anchor 30 m. As the anchor 30 m continues to be pushed through the exit opening 208 m, the sections 370 of the suture anchor retainer 280 m slide along the outer side surface 50 m on the suture anchor 30 m. When the anchor 30 m has been moved to a desired position relative to the tubular outer member 94 m, the outward movement of the anchor through the exit opening 208 m is interrupted. At this time, the sections 370 of the anchor retainer 280 m resiliently grip the cylindrical outer side surface 50 m of the anchor 30 m to hold the anchor against movement relative to the tubular outer member 94 m.

When the anchor 30 m is to be positioned relative to body tissue, the tubular outer member 94 m and the cylindrical suture anchor 50 m are aligned with an opening in the body tissue, in the same manner as is illustrated in FIG. 13. The tubular inner member 92 m is then moved toward the right (as viewed in FIG. 30) to push the anchor 30 m into the body tissue. The orientation of the anchor 30 m relative to the body tissue is then changed in the manner illustrated in FIG. 15 for the anchor inserter apparatus 22 c.

It is preferred to move the anchor 30 m to a position in which the leading end portion 44 m of the anchor extends axially outward from the tubular outer member 94 m and the retainer 280 m grips the outer side surface 50 m of the anchor. However, the anchor 30 m could remain completely within the passage 204 m in the tubular outer member 94 m if desired. If this is to be done, the force applied against the trailing end portion 38 m of the anchor 30 m by the inner member 92 m would press the leading end portion 44 m of the suture anchor against the surface 364 without deflecting the sections 370 of the suture retainer 280 m. Of course, when the anchor 30 m is to be positioned in body tissue, the force applied against the anchor 30 m by the inner member 92 m would be increased and the sections 370 of the retainer would be deflected in the manner previously explained.

In the embodiment of the invention illustrated in FIG. 30, the tubular outer member 94 m is formed of metal. The sections 370 of the anchor retainer 280 m are formed by first forming the slots 372 in the outer end of a cylindrical tubular member. The sections are then deflected inward to the positions shown in FIG. 30 to form the annular retainer 280 m. It should be understood that the tubular outer member 94 m and the retainer 280 m could be molded as one piece of polymeric material. If this was done, it is contemplated that it may be preferred to mold the sections 370 of the retainer 280 m in the orientation shown in FIG. 30.

The slots 372 separate the sections 370 of the anchor retainer 280 m and facilitate resilient deflection of the sections of the anchor retainer by the leading end portion 44 m of the anchor. However, the number of slots 372 and sections 370 could be reduced if desired. Thus, only a single slot, or perhaps two or three slots 372, could be formed in the tubular outer member 94 m. The resulting section or sections would then be plastically deformed to form the inner side surface 230 m of the passage 204 m into the frustrum of a cone of the suture anchor retainer 280 m. As was previously mentioned, the slots 372 could be completely eliminated if desired.

Anchor Inserter Apparatus

An alternative embodiment of the anchor inserter apparatus is illustrated in FIGS. 31–37. Since the embodiment of the anchor inserter apparatus illustrated in FIGS. 31–37 is generally similar to the embodiment of the suture anchor inserter apparatus illustrated in FIGS. 1–30, similar numerals will be utilized to designate similar components, the suffix letter “n” being added to the numerals of FIGS. 31–37 to avoid confusion.

An anchor inserter apparatus 20 n includes a tubular outer member 94 n (FIG. 31). The tubular outer member 94 n includes a one piece cylindrical tubular body 200 n. A cylindrical passage 204 n extends axially through the tubular outer member 94 n between a circular entrance opening 206 n and a circular exit opening 208 n. A straight longitudinally extending slot 102 n is formed in the tubular outer member 94 n and extends between the entrance opening 206 n and the exit opening 208 n.

A handle 22 n includes a cylindrical collar 380 which extends around the tubular outer member 94 n. The slot 102 n extends through the collar 380. The handle 22 n also includes an outwardly extending section 382 which is manually engageable to position the tubular outer member 94 n relative to body tissue. The section 382 has a longitudinal central axis which is skewed at an acute angle to the longitudinal central axis of the tubular outer member 94 n and the longitudinal central axis of the slot 102 n. The longitudinal central axis of the section 382 of the handle 22 n intersects the longitudinal central axis of the tubular outer member 94 n.

An anchor retainer 280 n is disposed adjacent to a leading end portion 242 n of the tubular outer member 94 n. The illustrated embodiment of the suture anchor retainer 280 n includes a projection 304 n having the same generally hemispherical configuration as the projection 304 g of FIGS. 24 and 25. The projection 304 n is disposed diametrically opposite from the slot 102 n. The projection 304 n has a central axis which extends perpendicular to and intersects the central axes of the passage 204 n and slot 102 n.

In accordance with a feature of this embodiment of the invention, two inner or pusher members are sequentially used in association with the tubular outer member 94 n. Thus, an anchor positioning push rod or inner member 386 (FIG. 32) is utilized to position an anchor relative to the tubular outer member 94 n and anchor retainer 280 n (FIG. 31). An anchor deployment push rod or inner member 388 (FIG. 33) is subsequently utilized to push the anchor out of the tubular outer member 94 n (FIG. 31). The anchor deployment push rod 388 (FIG. 33) is longer than the anchor positioning push rod 386 (FIG. 32).

The two inner members 386 and 388 (FIGS. 32 and 33) are sequentially inserted into the passage 204 n (FIG. 31) after the anchor has been inserted into the passage. Thus, when the anchor 30 n (FIG. 34) is to be initially positioned in the passage 204 n, the anchor positioning push rod 386 is inserted into the passage 204 n. A leading end surface 393 (FIG. 32) on the anchor positioning push rod 386 applies force to the trailing portion of the anchor 30 m (FIG. 35) to move the anchor along the passage 204 n. The anchor 30 n is moved to a position in which a trailing end portion of the anchor is disposed within the passage 204 n and a leading end portion of the anchor extends outwardly from the tubular outer member 94 n (FIG. 36). The anchor positioning push rod 386 is then withdrawn from the passage 204 n.

When the anchor 30 n is to be positioned relative to body tissue, the deployment push rod 388 (FIG. 33) is inserted into the passage 204 n. The anchor deployment push rod 388 is longer than the anchor positioning push rod 386. Therefore, the anchor deployment push rod 388 is effective to move the trailing end portion of the suture anchor out of the passage 204 n into body tissue.

The anchor positioning push rod or inner member 386 includes a cylindrical body 392 (FIG. 32). The body 392 has a circular end surface 393. A cylindrical stop or handle section 394 is connected with the cylindrical body 392. The stop or handle section 394 has an annular stop surface 396 which is coaxial with the cylindrical body 392 of the anchor positioning push rod or inner member.

The anchor deployment push rod 388 (FIG. 33) has a construction similar to the anchor positioning push rod 386 (FIG. 32). The anchor deployment push rod (FIG. 33) includes a cylindrical body 398. The cylindrical body 398 (FIG. 33) of the anchor deployment push rod 388 has a length which exceeds the length of the anchor positioning push rod 386 by more than the maximum depth to which an anchor is to be moved into body tissue. A cylindrical stop or handle section 400 is disposed in a coaxial relationship with the cylindrical body 398 of the anchor deployment push rod or inner member 388.

The cylindrical body 398 of the anchor deployment push rod or inner member 388 (FIG. 33) has indicia 404 which cooperates with an annular end surface 408 (FIG. 31) on the tubular outer member 94 to indicate the position of a leading end or pusher surface 410 on the anchor deployment push rod 388 (FIG. 33) relative to the tubular outer member 94. The indicia 404 (FIG. 33) cooperates with the end surface 408 (FIG. 31) on the tubular outer member 94 m to indicate the depth to which the anchor deployment push rod or inner member 388 has pushed the anchor 30 n (FIG. 36) into body tissue. The inner member 92 c of the embodiment of the invention illustrated in FIG. 11 could be provided with indicia corresponding to the indicia 404 if desired.

During assembly of the anchor inserter apparatus 20 n, an anchor 30 n (FIG. 34) is inserted into the passage 204 n in the tubular outer member 94 n. At this time, the suture 32 n may be connected with the suture anchor 30 n and the legs 62 n and 64 n are aligned with and extend through the slot 102 n in the tubular outer member 94 n. The anchor 30 n has an outside diameter which is smaller than the inside diameter of the portion of the passage 204 n ahead of the suture anchor retainer 280 n.

The cylindrical body 392 (FIG. 35) of the anchor positioning push rod 386 is inserted into the passage 204 n in the tubular outer member 94 n. The leading end surface 393 on the anchor positioning push rod 386 pushes the anchor 30 n toward the anchor retainer 280 n at the leading end portion 242 m of the tubular outer member 94 n. The leading end portion of the anchor 30 n applies force against and resiliently deflects a projection 304 n in the anchor retainer 280 n (FIGS. 35 and 37).

The projection 304 n has the same hemispherical configuration as the projection 304 g of FIG. 24. The projection 304 n (FIG. 37) is disposed opposite from the slot 102 n and has a central axis which extends perpendicular to and intersects parallel central axes of the tubular outer member 94 n and the slot 102 n. As the projection 304 n is resiliently deflected, the width of the slot 102 n opposite from the projection increases.

When the anchor 30 n has been moved to a desired position relative to the anchor retainer 280 n (FIG. 37), the stop surface 396 on the stop section 394 of the inner member 386 (FIG. 36) is in abutting engagement with the end surface 408 on the tubular member 94 n. At this time, the anchor 30 n is positioned with a leading end portion of the anchor extending outward from the tubular member 94 n and with a trailing end portion of the anchor 30 n disposed in the passage 204 n (FIG. 37). The anchor retainer 280 n is effective to firmly grip the anchor 30 n when the anchor is in the position shown in FIGS. 36 and 37.

The projection 304 n (FIG. 37) is effective to press the anchor 30 n against an inner side surface of the passage 204 n opposite from the projection 304 n. At this time, the tubular outer member 94 n is deflected by force applied against the projection 304 n and the inner side surface of the passage 204 n by the anchor 30 n. This deflection results in the width of the slot 102 n being greater adjacent to the anchor 30 n than at the opposite end of the tubular outer member 94 n.

The anchor positioning push rod 386 is then withdrawn from the passage 204 n in the tubular outer member 94 n. Since the anchor 30 n is firmly held by the anchor retainer 280 n, the anchor inserter apparatus 20 n can be moved from an assembly location to an operating room where the anchor inserter apparatus is to be utilized. The anchor deployment push rod 388 of FIG. 33 is moved to the operating room along with the tubular outer member 94 n and the anchor 30 n. However, the anchor positioning push rod 386 remains at the assembly location and is used to position another suture anchor relative to another tubular outer member.

At the operating room, the anchor deployment push rod 388 (FIG. 33) is inserted into the passage 204 n in the tubular outer member 94 n. Once the tubular outer member 94 n and the suture anchor 30 n have been positioned relative to body tissue, the anchor deployment push rod 388 is pressed against the trailing end of the anchor 30 n to force the anchor out of the tubular outer member 94 n into body tissue.

As the anchor deployment push rod 388 is inserted into the passage 204 n in the tubular outer member 94 n, the indicia 404 (FIG. 33) on the anchor deployment push rod cooperates with the end surface of the tubular outer member 94 n to indicate the position of the leading end 410 of the anchor deployment push rod 388 relative to the tubular outer member 94 n. Thus, the indicia 404 will indicate when the leading end 410 of the anchor deployment push rod has just moved into engagement with the trailing end of the anchor 30 n while the anchor 30 n is gripped by the anchor retainer 280 n. Continued movement of the anchor deployment push rod into the passage 204 n in the tubular outer member 94 n moves the indicia 404 relative to the end surface 408 on the tubular outer member 94 n. When the indicia indicates that the leading end 410 of the push rod deployment member 388 has moved the desired distance into the body tissue, the orientation of the suture anchor 30 n relative to the body tissue is changed in the manner illustrated schematically in FIGS. 13–15.

In the foregoing description it has been assumed that the inner members 386 and 388 will be sequentially moved relative to the tubular outer member 94 n. However, if desired, the tubular outer member 94 n could be moved relative to the inner members 386 and 388. Thus, the tubular outer member 94 n could be moved relative to the inner member 386 to position the anchor 30 n in engagement with the suture anchor retainer 280 n (FIG. 37). Similarly, the tubular outer member 94 n could be moved relative to the inner member 388 to separate the suture anchor 30 n from the tubular outer member.

In the foregoing description it has been assumed that the anchor 30 n would be moved along the passage 204 n into engagement with the anchor retainer 280 n. However, the anchor 30 n could be moved through the opening 208 n into engagement with the anchor retainer 280 n. If the anchor 30 n is moved through the opening 208 n into engagement with the suture anchor retainer 280 n, the inner member 386 may be positioned in the passage 204 n. The end surface 393 on the inner member 386 would then function as a stop to limit the extent of inward (leftward as viewed in FIG. 37) movement of the anchor relative to the tubular outer member 94 n.

One specific anchor retainer 280 n has been illustrated in FIG. 37. The anchor retainer 280 n has the same construction as the suture anchor retainer 280 g of FIGS. 24 and 25. However, it is contemplated that the anchor retainer 280 n of FIG. 37 could have the same construction as anyone of the anchor retainers previously described herein.

Tubular Outer Member with Insertion Funnel

In the embodiment of the invention illustrated in FIGS. 31–37, the tubular outer member 94 n has a cylindrical configuration. In the embodiment of the invention illustrated in FIG. 38, the tubular outer member has an outwardly flaring end portion to facilitate insertion of the anchor into the tubular member. Since the embodiment of the invention illustrated in FIG. 38 is generally similar to the embodiment of the invention illustrated in FIGS. 31–37, similar numerals will utilized to designate similar components, the suffix letter “p” being associated with the numerals of FIG. 38 to avoid confusion.

An anchor insertion apparatus 20 p includes a tubular outer member 94 p having a cylindrical central passage 204 p. A slot 102 p extends between opposite end portions of the tubular outer member 94 p. The slot 102 p also extends through a collar 380 p of a handle 22 p. In accordance with a feature of this embodiment of the invention, an outwardly flaring end portion or funnel 420 extends outward from the entrance opening 206 p to the passage 204 p. The funnel 420 has a side wall 424 with a generally conical configuration. The funnel 420 tapers from a relatively large end opening 426 to the entrance opening 206 p. The slot 102 p extends along the side wall 424 of the funnel 420.

When an anchor is to be moved into the passage 204 p in the tubular outer member 94 p, the anchor is moved into the funnel 420. A suture, which may be connected with the suture anchor, extends through the portion of the slot 102 p disposed in the side wall 424 of the funnel. The anchor is moved downward (as viewed in FIG. 38) through the funnel 420 to the entrance opening 206 p to the passage 204 p. The funnel 420 guides this movement of the anchor and aligns the suture anchor with the passage 204 p. The anchor positioning rod 386 and anchor deployment rod 388 of FIGS. 32 and 33 can be used with the anchor insertion apparatus 20 p of FIG. 38.

Indexing of Inner Member

In the embodiment of the invention illustrated in FIGS. 31–37, a relatively short anchor positioning rod 386 is utilized to position an anchor relative to an anchor retainer 280 n (FIGS. 36 and 37). A second inner member or deployment push rod 388 is longer than the anchor positioning push rod 386 and is used to move the anchor out of the passage 204 n into body tissue. In the embodiment of the invention illustrated in FIGS. 39 and 40, the same inner member is used to position the anchor relative to an anchor retainer and to move the anchor into body tissue. Since the embodiment of the invention illustrated in FIGS. 39 and 40 is generally similar to the embodiment of the invention illustrated in FIGS. 1–38, similar numerals will be utilized to designate similar components, the suffix letter “r” being associated with the numerals of FIGS. 39 and 40 to avoid confusion.

A anchor inserter apparatus 20 r includes a cylindrical inner member 92 r and a cylindrical tubular outer member 94 r. The outer member 94 r has the same construction as the outer member 94 n of FIG. 31. The outer member 94 r has a slot 102 r which extends between the circular entrance opening 206 r and an exit opening (not shown) corresponding to the exit opening 208 n of FIG. 31.

A handle 22 r is connected with the end portion of the tubular outer member 94 r adjacent to the entrance opening 206 r. An anchor retainer (not shown) is disposed adjacent to the exit opening from the tubular outer member 94 r. The anchor retainer connected with the tubular outer member 94 r has the same construction as illustrated in FIGS. 24, 25, 31 and 37.

In accordance with a feature of the embodiment of the invention illustrated in FIGS. 39 and 40, a stop or index pin 430 is connected with the inner member 92 r. When the inner member 92 r has moved an anchor to a predetermined position relative to an anchor retainer connected with the tubular outer member 94 r, in the manner illustrated in FIG. 37 for the anchor 30 n, the stop member 430 engages an annular end or stop surface 408 r on the tubular outer member 94 r (FIG. 39). At this time, the leading end of the inner member 92 r is disposed adjacent to an anchor retainer (not shown) connected with the outer end portion of the tubular outer member 94 r to position the anchor for engagement by the anchor retainer.

In the embodiment of the invention illustrated in FIGS. 39 and 40, the anchor retainer has the same construction as the anchor retainer 280 n of FIG. 37. However, it is contemplated that the anchor retainer could have a construction which is the same as the construction of any one of the anchor retainers illustrated in FIGS. 19–30. Engagement of the stop member 430 with the end surface 408 r on the tubular outer member 94 r limits telescopic movement of the inner member 92 r relative to the tubular outer member 94 r. Therefore, the anchor is positioned with a leading end portion of the anchor extending from the tubular outer member 94 r and a trailing end portion of the anchor disposed in a passage 204 r formed in the tubular outer member 94 r. At this time, the trailing end portion of the anchor is gripped by the anchor retainer.

When the anchor is to be positioned relative to body tissue, the inner member 92 r is rotated about its longitudinal central axis relative to the tubular outer member 94 r, in the manner indicated schematically by an arrow 434 in FIG. 39. As the inner member 92 r rotates about the longitudinal central axis of the passage 204 r, the stop member 430 is moved into alignment with the slot 102 r in the tubular outer member 94 r.

To disengage the anchor from the anchor retainer and to move the trailing end portion of the anchor from the passage 204 r into body tissue, the inner member 92 r is moved along coincident longitudinal central axes of the inner member and the outer member 94 r. As this occurs, the stop member 430 moves into the slot 102 r (FIG. 40). As the stop member 430 moves along the slot 102 r, the inner member 92 r applies force against the trailing end portion of the anchor to move the anchor out of the tubular outer member 94 r in the manner previously explained in conjunction with the embodiments of the invention illustrated in FIGS. 11–37.

As the inner member 92 r is telescopically moved into the outer member 94 r, indicia 404 r cooperates with the end surface 408 r (FIG. 40) to indicate the position of the leading end of the inner member 92 r and the anchor relative to the leading end of the outer member 94 r. When the indicia 404 r indicates that the inner member 92 r and anchor have been moved through a desired distance relative to the outer member 94 r, the orientation of the anchor is changed relative to the body tissue in the manner illustrated schematically in FIGS. 13–15 for the suture anchor 30 c.

Index Recess

In the embodiment of the invention illustrated in FIGS. 39 and 40, the stop member 430 is moved along the slot 102 r which extends between opposite ends of the tubular outer member 94 r. In the embodiment of the invention illustrated in FIG. 41, an index recess is provided to receive the stop member. Since the embodiment of the invention illustrated in FIG. 41 is generally similar to the embodiment of the invention illustrated in FIGS. 39 and 40, similar numerals will be utilized to designate similar components, the suffix letter “s” being associated with the numerals of FIG. 41 to avoid confusion.

A cylindrical inner member 92 s is telescopically received in a passage 204 s formed in a cylindrical tubular outer member 94 s. A handle 22 s is connected with the tubular outer member 94 s. The inner member 92 s is movable axially along the passage 204 s in the tubular outer member 94 s until a cylindrical stop member 430 s engages an annular stop surface 408 s on the tubular outer member 94 s.

Engagement of the stop member 430 s with the stop surface 408 s occurs when the suture anchor has been moved to a position relative to the tubular outer member 94 s in which a leading end portion of the suture anchor extends outward from the tubular outer member and a trailing end portion of the suture anchor is disposed in the passage 204 s. At this time, an anchor retainer having a construction similar to the construction of any one of the suture retainers illustrated in FIGS. 19–28 engages the anchor to hold it in a predetermined position relative to the tubular outer member 94 s. It is believed that it may be desired to utilize an anchor retainer having the same construction as the suture anchor retainer 280 n of FIGS. 31 and 37.

In accordance with a feature of the embodiment of the invention illustrated in FIG. 41, an index recess 440 is provided in the tubular outer member 94 s to receive the stop member 430. The index recess 440 is provided with a plurality of index surfaces 442, 444, and 446 which correspond to different depths of insertion of an anchor into body tissue. Thus, when the anchor is to be inserted a relatively short distance into the body tissue, the stop member 430 s is moved into engagement with the index surface 442 to limit relative movement of the inner member 92 s relative to the tubular outer member 94 s. If the anchor is to be inserted further into the body tissue, the stop member 430 s is moved into engagement with the index surface 444. If the anchor is to be inserted still further into the body tissue, the stop member 430 s is moved into engagement with the index surface 446.

The index recess 440 enables the stop member 430 s to move to a desired position relative to the tubular outer member 94 s without moving along the slot 102 s formed in the tubular outer member 94 s. In addition, the index recess 440 enables the depth of insertion of an anchor into body tissue to be controlled by engagement of the stop member 430 s with any one of the index surfaces 442, 444 or 446.

In the illustrated embodiment of the invention, the index surfaces 442, 444 and 446 are disposed in a single index recess. However, the index surfaces 442, 444 and 446 could be disposed in a plurality of index recesses. Thus, a plurality of different length slots could be formed in the tubular outer member 94 s with a different index surface at the end of each slot.

Deflectable Stop Member

In the embodiment of the invention illustrated in FIGS. 39–41, a stop member 430 r or 430 s is fixedly connected with an inner member. In the embodiment of the invention illustrated in FIG. 42, a stop member is yieldable relative to the inner member. Since the embodiment of the invention illustrated in FIG. 42 is generally similar to the embodiment of the invention illustrated in FIGS. 1–41, similar numerals will be utilized to designate similar components, the suffix letter “s” being associated with the numerals of FIG. 42 to avoid confusion.

A generally cylindrical inner member 92 t is received in a passage 204 t formed in a cylindrical tubular outer member 94 t. A handle 22 t is connected with the tubular outer member 94 t. A slot 102 t extends between openings at opposite ends of the tubular outer member 94 t. An anchor retainer (not shown) is disposed adjacent to the leading end of the tubular outer member 94 t.

In accordance with a feature of the embodiment of the invention illustrated in FIG. 42, a resiliently deflectable stop 450 is connected with the inner member 92 t. The stop 450 is engageable with the entrance opening 206 t to limit axial movement of the inner member 92 t relative to the outer member 94 t in the manner illustrated in FIG. 42. The stop 450 is formed of a resiliently deflectable material which, when axial force is applied against the inner member 92 t, is deflected radially inward and enters the passage 204 t in the tubular outer member 92 t. As this occurs, the inner member 92 t moves the suture anchor out of engagement with a suture anchor retainer (not shown) and into body tissue.

Suitable indicia 404 t is provided on the inner member 92 t. The indicia 404 t cooperates with an end surface 408 t on the tubular outer member 94 t to indicate the position of the inner member 92 t relative to the tubular outer member 94 t and the body tissue.

Forming of Opening in Body Tissue

When the anchor is to be positioned in hard body tissue, in a manner similar to that illustrated in FIGS. 13–15, a recess or opening is formed in the hard body tissue to receive the suture anchor. Since components of the embodiment of the invention illustrated in FIG. 43 are the same as components of the embodiments of the invention illustrated in FIGS. 1–42, similar numerals will be utilized to identify similar components, the suffix letter “u” being added to the numerals of FIG. 43 to avoid confusion.

In accordance with a feature of the embodiment of the invention illustrated in FIG. 43, the tubular outer member 94 u is used to guide movement of a cutting tool, such as a drill 460 relative, to hard body tissue or bone 252 u. Thus, the tubular outer member 94 u is used for the purpose of guiding movement of the cutting tool. The tubular outer member 94 u is also used to guide movement of an inner member and anchor, such as the inner member 92 c and anchor 30 c of FIG. 11.

When a recess or opening, corresponding to the opening 250 of FIG. 13, is to be formed in the bone 252 u (FIG. 43), a thin elongated member 464 is rotated about its central axis, in the manner indicated schematically by an arrow 466 in FIG. 43, by a suitable drill mechanism. As this occurs, the thin elongated member or K-wire 464 is moved axially into the bone. After the thin elongated member 464 has been moved to a desired depth into the bone, the tubular outer member 94 u of an anchor inserter apparatus having the same construction as the anchor inserter apparatus 20 c of FIG. 11, is axially positioned around the thin elongated member 464.

The drill 460 has a central passage 470 which enables the drill to be slid onto the thin elongated member 464. The tubular outer member 94 t is then positioned around the drill and moved into engagement with the bone 252 u in the manner illustrated in FIG. 43. The drill 460 is then rotated about the coincident longitudinal central axes of the thin elongated member 464 and the tubular outer member 94 u in the manner indicated schematically by an arrow 472 in FIG. 43.

As the drill is rotated, in the manner indicated by the arrow 472 in FIG. 43, the drill is moved axially relative to the stationary thin elongated member 464 and to the stationary tubular outer member 94 u. This axial movement of the drill slides the drill along the cylindrical outer side surface of the thin elongated member 464 and along an inner side surface 230 u of the tubular outer member. As this occurs, the drill forms an opening in the bone 252 u.

Indicia (not shown) may be provided on the drill. This indicia cooperates with the end of the tubular outer member 94 u to indicate the depth to which the drill has moved into the bone 252 u. The indicia on the drill cooperates with an end surface (not shown) on the tubular outer member 94 u in the same manner as in which the indicia 404 (FIG. 33) on the inner member 388 cooperates with the end surface 408 on the tubular outer member. If desired, a stop could be connected with the drill 460 (FIG. 43) and moved into engagement with the end surface on the tubular outer member to limit axial movement of the drill into the bone 252 u.

When the drill 460 (FIG. 43) has moved to a desired depth in the bone 252 u, the drill is axially withdrawn from the thin elongated member. The thin elongated member extends further into the bone 252 u than the distance which the drill enters the bone. Therefore, the thin elongated member 464 remains in place as the drill 460 is withdrawn from the thin elongated member.

The tubular outer member 94 t is maintained stationary relative to the bone 252 u as the drill 460 is withdrawn from the thin elongated member. The orientation of both the thin elongated member 464 and the tubular outer member 94 t are maintained constant relative to the bone 252 u after the drill has been withdrawn from the passage 204 u in the tubular outer member 94 u. The tubular outer member 94 u may be held stationary relative to the bone 252 u by clamping the portion of the patient containing the bone to a base plate and by fixedly connecting the tubular outer member 94 t with the base plate.

Once the opening has been drilled to the desired depth in the bone 252 t and the drill 460 disengaged from the thin elongated member 464 and tubular outer member 94 t, the anchor is moved along the thin elongated member 464 into the tubular outer member 94 u. This results in the anchor being guided into the opening formed in the bone 252 u by the thin elongated member. The anchor is moved into the opening formed in the bone by movement of a tubular inner member, corresponding to the inner member 92 c of FIG. 11, axially along the thin elongated member and into the tubular outer member 94 u.

CONCLUSION

The present invention relates to a new and improved method and apparatus 20 (FIGS. 1–43) for use in positioning an anchor 30 during assembly of the apparatus. The invention also relates to a new and improved apparatus 20 (FIGS. 1–43) for use in positioning an anchor 30 relative to body tissue during use of the apparatus. The apparatus 20 includes a tubular outer member 94 and an inner member 92 which is received in a passage 204 in the tubular outer member.

A slot 102 may extend between openings 206 and 208 at opposite ends of the tubular outer member 94. During positioning of the anchor 30 relative to body tissue 88 or 252, the slot 102 facilitates visualization of the anchor by a surgeon. Stop surfaces 396, 410, and 430 may be provided in association with the inner and outer members 92 and 94 to facilitate moving the anchor 30 to a desired position relative to the inner and outer members during relative movement between the inner and outer members.

In addition, the apparatus 20 may includes a retainer 280 which holds an anchor 30 in a desired position relative to the apparatus during assembly of the apparatus and during positioning of the anchor relative to body tissue. The retainer 280 is deflected under the influence of force applied against the retainer by the anchor 30 to enable the retainer to grip the anchor and hold the suture anchor in the desired position.

The retainer 280 may engage a recess 300, 236, or 238 in the anchor 30. The recess may be formed by a passage in the anchor. Alternatively, the recess may be formed in an outer side surface of the anchor.

During positioning of the anchor 30 relative to body tissue 88 or 252, the tubular outer member 94 may be utilized as a guide for a drill 460 which forms an opening in the body tissue. After the opening has been formed in the body tissue, the drill 460 is removed from the tubular outer member 94 and the anchor 30 is moved along the tubular outer member 94 into the body tissue. 

1. A method of positioning an anchor in body tissue, said method comprising the steps of providing an anchor farmed of a hydrophilic material, positioning an inserter in an opening in the anchor formed of hydrophilic material with a pointed end portion of the inserter extending from the anchor formed of hydrophilic material, piercing body tissue with the pointed end portion of the inserter, disengaging the anchor formed of hydrophilic material from the inserter with the anchor formed of hydrophilic material disposed in the body tissue, and exposing the anchor formed of hydrophilic material to body fluids.
 2. A method as set forth in claim 1 further including the step of changing the orientation of the anchor formed of hydrophilic material relative to the body tissue, said step of changing the orientation of the anchor formed of hydrophilic material includes displacing body tissue under the influence of force applied against the body tissue by the anchor formed of hydrophilic material.
 3. A method as set forth in claim 2 wherein the step of changing the orientation of the anchor formed of hydrophilic material relative to the body tissue is at least partially performed with a portion of the inserter enclosed by the anchor formed of hydrophilic material.
 4. A method as set forth in claim 2 wherein said step of displacing body tissue under the influence of force applied against the body tissue by the anchor formed of hydrophilic material includes transmitting farce between the inserter and the anchor formed of hydrophilic material.
 5. A method as set forth in claim 1 further including the step of applying torque to the anchor formed of hydrophilic material to rotate the anchor formed of hydrophilic material relative to the body tissue and change the orientation of the anchor relative to the body tissue.
 6. A method as set forth in claim 1 wherein said step of positioning an inserter in an opening in the anchor formed of hydrophilic material and said step of disengaging the anchor formed of hydrophilic mater from the inserter are performed with a suture connected with the anchor formed of hydrophilic material.
 7. A method as set forth in claim 1 further including the step of tensioning a suture connected with the anchor formed of hydrophilic material.
 8. A method ass set forth in claim 1 wherein said step of disengaging the anchor formed of hydrophilic material from the inserter includes applying force against a trailing end portion of the anchor formed of hydrophilic material to move the anchor formed of hydrophilic material along the pointed end portion of the inserter.
 9. A method as set forth in claim 1 wherein said step of piercing the body tissue with the pointed end portion of the inserter includes piercing an imperforate surface area on the body tissue with the pointed end portion of the inserter.
 10. A method as set forth in claim 1 further including the step of applying force against a trailing end portion of the anchor formed of hydrophilic material with the inserter to move a leading end portion of the anchor formed of hydrophilic through an opening formed in the body tissue by piercing the body tissue with the pointed end portion of the inserter.
 11. A method of positioning an anchor in body tissue, said method comprising the steps of providing an anchor formed of hydrophilic material and having an opening extending through the anchor formed of hydrophilic material, inserting a member having pointed end portion through the opening extending through the anchor formed of hydrophilic material to a position in which the pointed end portion of the member is at least partially disposed ahead of a leading end portion of the anchor formed of hydrophilic material, piercing body tissue with the pointed end portion of the member, applying a force against a trialing end portion of the author formed of hydrophilic material to move the leading end portion of the anchor formed of hydrophilic material through an opening which is at least partially formed in the body tissue by piercing the body tissue with the pointed end portion of the member, moving the trailing end portion of the anchor formed of hydrophilic material through the opening which is at least partially formed in the body tissue with the pointed end portion of the member by applying force against the trailing end portion of the anchor formed of hydrophilic material, disengaging the member from the anchor formed of hydrophilic material, exposing the anchor formed of hydrophilic material to body fluid, and expanding the anchor formed of hydrophilic material while the anchor formed of hydrophilic material is disposed in the body tissue.
 12. A method as set forth in claim 11 further including the step of changing the orientation of the anchor formed of hydrophilic material relative to the body tissue while applying force against the trailing end portion of the anchor formed of hydrophilic material.
 13. A method as set forth in claim 11 wherein said step of moving the trailing end portion of the anchor formed of hydrophilic material through the opening in the body tissue is performed with a suture extending into the opening through the anchor formed of hydrophilic material. 